NCT02432274 · OUTCOME
Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
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
- From date of first dose of study drug until PD or death, whichever occurred first (Cohort 1, 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
BOR: best response of CR or PR for \>4 weeks or SD for \>=7 weeks from first dose, recorded from start of treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have reduction in their short axis \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Not evaluable (NE) means BOR of NE or SD of \<7 weeks duration. Unknown means no data were available on the case report form.
Analysis population: Full analysis set included all enrolled participants who did not fail study screening. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
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.
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 | Source count |
|---|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 3 |
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 9 |
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 10 |
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 30 |
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 7 |
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 14 |
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 18 |
Reported measurements
Complete Response
| 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 |
| 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 |
Partial Response
| 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 |
| 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 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| 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 | 5 | 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 |
| 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 10 | 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 |
Progressive Disease
| 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 12 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable or Unknown
| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 3 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
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- 0
- group Id
- OG003
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- group Id
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- value
- 0
- group Id
- OG006
- value
- 0
- title
- Complete Response
- categories
- measurements
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- 2
- group Id
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- value
- 2
- group Id
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- value
- 0
- group Id
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- value
- 3
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 9
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- title
- Not Evaluable or Unknown
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 18
- units
- Participants
- description
- BOR: best response of CR or PR for \>4 weeks or SD for \>=7 weeks from first dose, recorded from start of treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have reduction in their short axis \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Not evaluable (NE) means BOR of NE or SD of \<7 weeks duration. Unknown means no data were available on the case report form.
- 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 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- title
- Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set included all enrolled participants who did not fail study screening. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From date of first dose of study drug until PD or death, whichever occurred first (Cohort 1, 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, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
- type
- SECONDARY
- unit Of Measure
- Participants
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