NCT02432274 · OUTCOME
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma · Source last updated 2023-07-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure COUNT_OF_PARTICIPANTS
Unit Participants
Interval / dispersion Not reported
Time frame First dose of study drug until 30 days after last dose of study drug (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019) What was measured TEAEs (serious and non-serious), those occurred most frequently have been reported in this outcome measure. "Palmar-plantar E syndrome" refers to Palmar-plantar erythrodysaesthesia syndrome.
Analysis population: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
Groups in this outcome Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 5 Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 11 Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 7 Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 1 Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 31 Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 11 Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 11 Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 20
Reported measurements Hypothyroidism Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 13 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 6 Not reported Not reported Not reported Not reported
Abdominal pain Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 6 Not reported Not reported Not reported Not reported
Diarrhea Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 8 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 12 Not reported Not reported Not reported Not reported
Nausea Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 8 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 7 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 8 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 13 Not reported Not reported Not reported Not reported
Vomiting Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 7 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 12 Not reported Not reported Not reported Not reported
Asthenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 8 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 7 Not reported Not reported Not reported Not reported
Fatigue Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 8 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported
Alanine aminotransferase increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Blood thyroid stimulating hormone increased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 9 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported
Weight decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Decreased appetite Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 13 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported
Arthralgia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported
Myalgia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Pain in extremity Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Headache Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Proteinuria Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 7 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 8 Not reported Not reported Not reported Not reported
Dysphonia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Erythema Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Hair color changes Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Palmar-plantar E syndrome Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Hypertension Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 10 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported
Haematuria Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Hypokalaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported
Hypophosphataemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported
Platelet count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 11 Not reported Not reported Not reported Not reported
Back pain Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported
Dry skin Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Oral pain Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported
Pneumothorax Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported
Dehydration Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Hypoalbuminaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Lethargy Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported
Leukopenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported
Neutrophil count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 9 Not reported Not reported Not reported Not reported
Oral dysaesthesia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Oropharyngeal pain Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported
Proctalgia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Toxic encephalopathy Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Lymphocyte count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Abdominal pain upper Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Hyperuricemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Insomnia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 1 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Anaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 9 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 7 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 15 Not reported Not reported Not reported Not reported
Neutropenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 6 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 8 Not reported Not reported Not reported Not reported
Epistaxis Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Thrombocytopenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 5 Not reported Not reported Not reported Not reported
Febrile neutropenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported
Stomatitis Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 4 Not reported Not reported Not reported Not reported
Constipation Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 5 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported
White blood cell count decreased Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 4 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 3 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 12 Not reported Not reported Not reported Not reported
Lymphopenia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Haematochezia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Pyrexia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Wound dehiscence Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Hypocalcaemia Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Dizziness Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Dyspnoea Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Hyperhidrosis Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 0 Not reported Not reported Not reported Not reported Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 2 Not reported Not reported Not reported Not reported Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 3
group Id OG001
value 6
group Id OG002
value 3
group Id OG003
value 0
group Id OG004
value 13
group Id OG005
value 5
group Id OG006
value 6
group Id OG007
value 6
title Hypothyroidism categories measurements
group Id OG000
value 2
group Id OG001
value 2
group Id OG002
value 1
group Id OG003
value 1
group Id OG004
value 5
group Id OG005
value 6
group Id OG006
value 5
group Id OG007
value 6
title Abdominal pain categories measurements
group Id OG000
value 3
group Id OG001
value 5
group Id OG002
value 3
group Id OG003
value 1
group Id OG004
value 8
group Id OG005
value 5
group Id OG006
value 5
group Id OG007
value 12
title Diarrhea categories measurements
group Id OG000
value 1
group Id OG001
value 2
group Id OG002
value 3
group Id OG003
value 0
group Id OG004
value 8
group Id OG005
value 7
group Id OG006
value 8
group Id OG007
value 13
title Nausea categories measurements
group Id OG000
value 1
group Id OG001
value 6
group Id OG002
value 3
group Id OG003
value 0
group Id OG004
value 7
group Id OG005
value 5
group Id OG006
value 6
group Id OG007
value 12
title Vomiting categories measurements
group Id OG000
value 2
group Id OG001
value 1
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 8
group Id OG005
value 0
group Id OG006
value 0
group Id OG007
value 7
title Asthenia categories measurements
group Id OG000
value 2
group Id OG001
value 2
group Id OG002
value 3
group Id OG003
value 0
group Id OG004
value 8
group Id OG005
value 2
group Id OG006
value 4
group Id OG007
value 3
title Fatigue categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 1
group Id OG003
value 0
group Id OG004
value 1
group Id OG005
value 3
group Id OG006
value 1
group Id OG007
value 4
title Alanine aminotransferase increased categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 9
group Id OG005
value 3
group Id OG006
value 0
group Id OG007
value 5
title Blood thyroid stimulating hormone increased categories measurements
group Id OG000
value 3
group Id OG001
value 4
group Id OG002
value 1
group Id OG003
value 0
group Id OG004
value 6
group Id OG005
value 5
group Id OG006
value 3
group Id OG007
value 4
title Weight decreased categories measurements
group Id OG000
value 3
group Id OG001
value 5
group Id OG002
value 1
group Id OG003
value 0
group Id OG004
value 13
group Id OG005
value 4
group Id OG006
value 2
group Id OG007
value 5
title Decreased appetite categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 1
group Id OG003
value 0
group Id OG004
value 1
group Id OG005
value 2
group Id OG006
value 4
group Id OG007
value 1
title Arthralgia Show more (12 of 58) denoms counts
group Id OG000
value 5
group Id OG001
value 11
group Id OG002
value 7
group Id OG003
value 1
group Id OG004
value 31
group Id OG005
value 11
group Id OG006
value 11
group Id OG007
value 20
units Participants
description TEAEs (serious and non-serious), those occurred most frequently have been reported in this outcome measure. "Palmar-plantar E syndrome" refers to Palmar-plantar erythrodysaesthesia syndrome. groups
description Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
id OG000
title Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
description Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
id OG001
title Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
description Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
id OG002
title Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
description Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
id OG003
title Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
description Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
id OG004
title Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
description Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
id OG005
title Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
description Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
id OG006
title Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
description Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
id OG007
title Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
param Type COUNT_OF_PARTICIPANTS
population Description Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
reporting Status POSTED
time Frame First dose of study drug until 30 days after last dose of study drug (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)
title Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
type SECONDARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle