TriangleNCT02432274 · OUTCOME
Cohorts 1, 2A, 2B, 3A and 3B: Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose of study drug until death (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
OS was defined as the time from the date of the first dose of study drug until the date of death from any cause. Participants who are lost to follow-up and those who are alive at the date of data cutoff were censored at the date the participant was last known to be alive (or the data cutoff date). 95% CI of median were calculated according to Brookmeyer and Crowley method.
Analysis population: Full analysis set included all enrolled participants who did not fail study screening.
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 | 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 | 11 |
| 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 | 7 |
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 15 |
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2 | 8.1 | Not reported | 3.8 | NA | Upper limit of 95% CI could not be estimated due to low number of participants with events. |
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 7.4 | Not reported | 1.3 | NA | Upper limit of 95% CI could not be estimated due to low number of participants with events. |
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 7.7 | Not reported | 2.7 | NA | Upper limit of 95% CI could not be estimated due to low number of participants with events. |
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 6.1 | Not reported | NA | NA | 95% CI could not be estimated as insufficient number of participants were available for analysis. |
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 10.0 | Not reported | 5.6 | 12.3 | Not reported |
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 13.6 | Not reported | 2.4 | 28.0 | Not reported |
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | NA | Not reported | 8.8 | NA | Median and upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis. |
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | NA | Not reported | 7.3 | NA | Median and upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI could not be estimated due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 3.8
- upper Limit
- NA
- value
- 8.1
- comment
- Upper limit of 95% CI could not be estimated due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- NA
- value
- 7.4
- comment
- Upper limit of 95% CI could not be estimated due to low number of participants with events.
- group Id
- OG002
- lower Limit
- 2.7
- upper Limit
- NA
- value
- 7.7
- comment
- 95% CI could not be estimated as insufficient number of participants were available for analysis.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.1
- group Id
- OG004
- lower Limit
- 5.6
- upper Limit
- 12.3
- value
- 10.0
- group Id
- OG005
- lower Limit
- 2.4
- upper Limit
- 28.0
- value
- 13.6
- comment
- Median and upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
- group Id
- OG006
- lower Limit
- 8.8
- upper Limit
- NA
- value
- NA
- comment
- Median and upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
- group Id
- OG007
- lower Limit
- 7.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 31
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 15
- group Id
- OG007
- value
- 20
- units
- Participants
- description
- OS was defined as the time from the date of the first dose of study drug until the date of death from any cause. Participants who are lost to follow-up and those who are alive at the date of data cutoff were censored at the date the participant was last known to be alive (or the data cutoff date). 95% CI of median were calculated according to Brookmeyer and Crowley method.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Full analysis set included all enrolled participants who did not fail study screening.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until death (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: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice