TriangleNCT04238819 · OUTCOME
Progression-Free Survival (PFS): Part C
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Months
- Interval / dispersion
- Not reported
- Time frame
- Date of first dose to progressive disease or death (Up to 25 Months)
What was measured
Progression-free survival is measured as the time from first dose of study drug to progressive disease or death, whichever occurs first. PFS for Part C was reported.
Analysis population: All part C participants who received at least one dose of study drug. However, Part C was terminated early and only 1 participant was enrolled in this part.
Groups in this outcome
Part C Cohort C1
Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. * Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle. * Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
| Group | Source count |
|---|---|
| Part C Cohort C1 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C Cohort C1 | 2.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2.9
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- Progression-free survival is measured as the time from first dose of study drug to progressive disease or death, whichever occurs first. PFS for Part C was reported.
- groups
- description
- Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. * Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle. * Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG000
- title
- Part C Cohort C1
- param Type
- NUMBER
- population Description
- All part C participants who received at least one dose of study drug. However, Part C was terminated early and only 1 participant was enrolled in this part.
- reporting Status
- POSTED
- time Frame
- Date of first dose to progressive disease or death (Up to 25 Months)
- title
- Progression-Free Survival (PFS): Part C
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice