NCT02432274 · OUTCOME
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
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
- MEAN
- Unit
- nanogram per milliliter (ng/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cohorts 1, 2A, 2B: Cycle(C)1 Day(D)1: 0.5-4 hours (h), 6-10 h post-dose, C1D15: pre-dose, 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose; Cohorts 3A, 3B: C1D1: 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose
What was measured
Duration of each cycle for Cohorts 1, 2A, 2B is 28 days. Duration of each cycle for Cohorts 3A, 3B is 21 days.
Analysis population: Pharmacokinetic (PK) Analysis Set included all participants who had received any study drug and had evaluable PK data. Here "number analyzed, n" signifies participants who were evaluable for this outcome measure at given time points.
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
Cycle 1 Day 1: 0.5-4 hours
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 | 29 |
|---|
| 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 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 295.6 | 214.01 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 134.8 | 145.83 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 52.5 | 81.40 | Not reported | Not reported | Not reported |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 11.1 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was available for analysis. |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 177.4 | 191.03 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 105.2 | 131.54 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 111.4 | 131.47 | Not reported | Not reported | Not reported |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 209.7 | 197.66 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 1: 6-10 hours
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 | 30 |
|---|
| 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 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 212.7 | 185.98 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 281.9 | 137.39 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 238.0 | 135.87 | Not reported | Not reported | Not reported |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 188 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was available for analysis. |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 289.4 | 200.09 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 191.9 | 100.69 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 148.5 | 122.41 | Not reported | Not reported | Not reported |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 164.8 | 73.59 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 15: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 4 |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 9 |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 6 |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 1 |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 29 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 0 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 0 |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 0 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 46.9 | 11.01 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 59.1 | 29.19 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 96.9 | 66.10 | Not reported | Not reported | Not reported |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 56.2 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was available for analysis. |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 67.0 | 53.78 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 15: 0.5-4 hours
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 4 |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 8 |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 6 |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 1 |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 28 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 0 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 0 |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 0 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 133.4 | 163.37 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 226.6 | 204.61 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 191.8 | 190.22 | Not reported | Not reported | Not reported |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 124 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was available for analysis. |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 168.3 | 157.67 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 15: 6-10 hours
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 4 |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 8 |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 6 |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 1 |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 29 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 0 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 0 |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 0 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 351.8 | 157.15 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 375.8 | 121.21 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 413.0 | 221.47 | Not reported | Not reported | Not reported |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 247 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was available for analysis. |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 322.9 | 138.87 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1: Pre-dose
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 | 8 |
|---|
| 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 | 27 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 11 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 8 |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 17 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 58.1 | 19.58 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 61.6 | 60.61 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 97.9 | 77.08 | Not reported | Not reported | Not reported |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 59.8 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was available for analysis. |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 66.8 | 62.50 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 51.7 | 44.23 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 76.1 | 63.25 | Not reported | Not reported | Not reported |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 50.4 | 65.10 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1: 2-12 hours
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 | 7 |
|---|
| 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 | 28 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 11 |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 9 |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 18 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 502.4 | 360.71 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 440.7 | 229.29 | Not reported | Not reported | Not reported |
|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 339.2 | 212.44 | Not reported | Not reported | Not reported |
|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 102 | NA | Not reported | Not reported | Standard deviation could not be calculated because only one participant was available for analysis. |
|---|
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 382.4 | 217.49 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 205.6 | 134.66 | Not reported | Not reported | Not reported |
|---|
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 237.4 | 124.82 | Not reported | Not reported | Not reported |
|---|
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 275.3 | 135.73 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 214.01
- value
- 295.6
- group Id
- OG001
- spread
- 145.83
- value
- 134.8
- group Id
- OG002
- spread
- 81.40
- value
- 52.5
- comment
- Standard deviation could not be calculated because only one participant was available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 11.1
- group Id
- OG004
- spread
- 191.03
- value
- 177.4
- group Id
- OG005
- spread
- 131.54
- value
- 105.2
- group Id
- OG006
- spread
- 131.47
- value
- 111.4
- group Id
- OG007
- spread
- 197.66
- value
- 209.7
- 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
- 29
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 20
- units
- Participants
- title
- Cycle 1 Day 1: 0.5-4 hours
- categories
- measurements
- group Id
- OG000
- spread
- 185.98
- value
- 212.7
- group Id
- OG001
- spread
- 137.39
- value
- 281.9
- group Id
- OG002
- spread
- 135.87
- value
- 238.0
- comment
- Standard deviation could not be calculated because only one participant was available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 188
- group Id
- OG004
- spread
- 200.09
- value
- 289.4
- group Id
- OG005
- spread
- 100.69
- value
- 191.9
- group Id
- OG006
- spread
- 122.41
- value
- 148.5
- group Id
- OG007
- spread
- 73.59
- value
- 164.8
- 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
- 30
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 20
- units
- Participants
- title
- Cycle 1 Day 1: 6-10 hours
- categories
- measurements
- group Id
- OG000
- spread
- 11.01
- value
- 46.9
- group Id
- OG001
- spread
- 29.19
- value
- 59.1
- group Id
- OG002
- spread
- 66.10
- value
- 96.9
- comment
- Standard deviation could not be calculated because only one participant was available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 56.2
- group Id
- OG004
- spread
- 53.78
- value
- 67.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 29
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 163.37
- value
- 133.4
- group Id
- OG001
- spread
- 204.61
- value
- 226.6
- group Id
- OG002
- spread
- 190.22
- value
- 191.8
- comment
- Standard deviation could not be calculated because only one participant was available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 124
- group Id
- OG004
- spread
- 157.67
- value
- 168.3
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 28
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15: 0.5-4 hours
- categories
- measurements
- group Id
- OG000
- spread
- 157.15
- value
- 351.8
- group Id
- OG001
- spread
- 121.21
- value
- 375.8
- group Id
- OG002
- spread
- 221.47
- value
- 413.0
- comment
- Standard deviation could not be calculated because only one participant was available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 247
- group Id
- OG004
- spread
- 138.87
- value
- 322.9
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 29
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15: 6-10 hours
- categories
- measurements
- group Id
- OG000
- spread
- 19.58
- value
- 58.1
- group Id
- OG001
- spread
- 60.61
- value
- 61.6
- group Id
- OG002
- spread
- 77.08
- value
- 97.9
- comment
- Standard deviation could not be calculated because only one participant was available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 59.8
- group Id
- OG004
- spread
- 62.50
- value
- 66.8
- group Id
- OG005
- spread
- 44.23
- value
- 51.7
- group Id
- OG006
- spread
- 63.25
- value
- 76.1
- group Id
- OG007
- spread
- 65.10
- value
- 50.4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 27
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 17
- units
- Participants
- title
- Cycle 2 Day 1: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 360.71
- value
- 502.4
- group Id
- OG001
- spread
- 229.29
- value
- 440.7
- group Id
- OG002
- spread
- 212.44
- value
- 339.2
- comment
- Standard deviation could not be calculated because only one participant was available for analysis.
- group Id
- OG003
- spread
- NA
- value
- 102
- group Id
- OG004
- spread
- 217.49
- value
- 382.4
- group Id
- OG005
- spread
- 134.66
- value
- 205.6
- group Id
- OG006
- spread
- 124.82
- value
- 237.4
- group Id
- OG007
- spread
- 135.73
- value
- 275.3
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 28
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 18
- units
- Participants
- title
- Cycle 2 Day 1: 2-12 hours
- 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
- Duration of each cycle for Cohorts 1, 2A, 2B is 28 days. Duration of each cycle for Cohorts 3A, 3B is 21 days.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Pharmacokinetic (PK) Analysis Set included all participants who had received any study drug and had evaluable PK data. Here "number analyzed, n" signifies participants who were evaluable for this outcome measure at given time points.
- reporting Status
- POSTED
- time Frame
- Cohorts 1, 2A, 2B: Cycle(C)1 Day(D)1: 0.5-4 hours (h), 6-10 h post-dose, C1D15: pre-dose, 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose; Cohorts 3A, 3B: C1D1: 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose
- title
- Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
- type
- SECONDARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle