TriangleNCT04238819 · OUTCOME
Maximum Tolerated Dose (MTD) of Abemaciclib in Part A
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
- Cycle 1 (21 Days)
What was measured
The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.
Analysis population: All part A participants who received at least one dose of abemaciclib and had evaluable data for this outcome.
Groups in this outcome
Part A - Abemaciclib
* Cohort A1: 70 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle. * Cohort A-1: 55 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.
| Group | Source count |
|---|---|
| Part A - Abemaciclib | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A - Abemaciclib | 55 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 55
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.
- groups
- description
- * Cohort A1: 70 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle. * Cohort A-1: 55 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.
- id
- OG000
- title
- Part A - Abemaciclib
- param Type
- NUMBER
- population Description
- All part A participants who received at least one dose of abemaciclib and had evaluable data for this outcome.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (21 Days)
- title
- Maximum Tolerated Dose (MTD) of Abemaciclib in Part A
- type
- PRIMARY
- unit Of Measure
- mg/m² BID
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice