TriangleNCT02432274 · OUTCOME
Cohort 2A: 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 first dose of study drug until PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)
What was measured
BOR was defined as the best response of CR or PR for \>4 weeks or SD for \>=7 weeks recorded from the start of the 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 a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the 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.
Analysis population: Full analysis set included all enrolled participants who did not fail study screening.
Groups in this outcome
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.
| Group | Source count |
|---|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 1 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Stable Disease
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- BOR was defined as the best response of CR or PR for \>4 weeks or SD for \>=7 weeks recorded from the start of the 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 a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the 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.
- groups
- 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
- OG000
- title
- Cohort 2A, Single-agent Expansion, DTC: 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.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)
- title
- Cohort 2A: Number of Participants With Best Overall Response (BOR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice