TriangleNCT02432274 · OUTCOME
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
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
- Cycle 1 Day 1 (Cycle length=28 days for Cohorts 1, 2A, 2B; Cycle length=21 days for Cohorts 3A, 3B)
What was measured
In acceptability questionnaire, participants were asked to answer the overall acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell and how does it feel in the mouth. Overall acceptability was answered in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. Overall acceptability was the overall acceptance for taste, appearance, smell, and the feeling in mouth. In this measure, number of participants have been reported per their overall acceptability responses.
Analysis population: Palatability analysis set included all participants who received oral suspension of lenvatinib and answered at least 1 question in the palatability questionnaire case report form.
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 | 0 |
| Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2 | 2 |
| Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2 | 1 |
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 0 |
| Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2 | 1 |
| Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2 | 0 |
| Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2 | 1 |
| Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2 | 4 |
Reported measurements
Super Good
| 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 | 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 |
Really Good
| 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 | 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 |
Good
| 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 | 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 | 1 | 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 |
May be Good or May be Bad
| 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 | 0 | 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 |
Bad
| 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 | 0 | 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 |
Really Bad
| 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 | 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 | 0 | 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 |
Super Bad
| 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 | 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 |
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- units
- Participants
- description
- In acceptability questionnaire, participants were asked to answer the overall acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell and how does it feel in the mouth. Overall acceptability was answered in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. Overall acceptability was the overall acceptance for taste, appearance, smell, and the feeling in mouth. In this measure, number of participants have been reported per their overall acceptability responses.
- 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
- Palatability analysis set included all participants who received oral suspension of lenvatinib and answered at least 1 question in the palatability questionnaire case report form.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (Cycle length=28 days for Cohorts 1, 2A, 2B; Cycle length=21 days for Cohorts 3A, 3B)
- title
- Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice