TriangleNCT04238819 · OUTCOME
RP2D of Abemaciclib in Combination With Temozolomide (Part B)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m² BID
- Interval / dispersion
- Not reported
- Time frame
- Cycles 1 and 2 (21 Day Cycles)
What was measured
The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 150 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
Analysis population: All participants in Part B who received at least one dose of abemaciclib and had evaluable data for this outcome.
Groups in this outcome
Part B - Abemaciclib
Participants received: * Abemaciclib: 70 mg/m² or 90 mg/m² or 115 mg/m², administered orally BID. * Temozolomide: 100 mg/m²/day or 150 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
| Group | Source count |
|---|---|
| Part B - Abemaciclib | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B - Abemaciclib | 115 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 115
- denoms
- counts
- group Id
- OG000
- value
- 26
- units
- Participants
- description
- The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 150 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
- groups
- description
- Participants received: * Abemaciclib: 70 mg/m² or 90 mg/m² or 115 mg/m², administered orally BID. * Temozolomide: 100 mg/m²/day or 150 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG000
- title
- Part B - Abemaciclib
- param Type
- NUMBER
- population Description
- All participants in Part B who received at least one dose of abemaciclib and had evaluable data for this outcome.
- reporting Status
- POSTED
- time Frame
- Cycles 1 and 2 (21 Day Cycles)
- title
- RP2D of Abemaciclib in Combination With Temozolomide (Part B)
- type
- PRIMARY
- unit Of Measure
- mg/m² BID
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice