TriangleNCT04238819 · OUTCOME
Abemaciclib Tablet Acceptability
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 1 Day 15, and Cycle 2 Day 1 (21 Day Cycles)
What was measured
Participants were evaluated for abemaciclib acceptability (palatability and ease of administration) by asking a question - " Was it easy or difficult for the study subject to swallow the abemaciclib today?" Participants or their caregivers or both could respond using the following possible answers: Very difficult, difficult, neither easy nor difficult, easy, or very easy.
Analysis population: All participants in Parts A and B, who received at least one dose of abemaciclib and had evaluable data for this outcome. Per protocol, data were summarized by responses provided by participants, and/or caregivers on the acceptability of the abemaciclib received on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1.
Groups in this outcome
Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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.
Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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.
Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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.
Part A Cohort A1 (Participant Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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.
Part A Cohort A1 (Participant Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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.
Part A Cohort A1 (Participant Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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.
Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1)
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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15)
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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1)
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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Part A Cohort A-1(Participant Responses - Cycle 1 Day 1)
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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Part A Cohort A-1(Participant Responses - Cycle 1 Day 15)
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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Part A Cohort A-1(Participant Responses - Cycle 2 Day 1)
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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B1 (Participant Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B1 (Participant Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B1 (Participant Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B2 (Participant Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B2 (Participant Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B2 (Participant Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B3 (Participant Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B3 (Participant Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B3 (Participant Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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.
Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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.
Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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.
Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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.
Part B Cohort B5 (Participant Responses - Cycle 1 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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.
Part B Cohort B5 (Participant Responses - Cycle 1 Day 15)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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.
Part B Cohort B5 (Participant Responses - Cycle 2 Day 1)
Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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 A Cohort A1 (Caregiver Responses - Cycle 1 Day 1) | 3 |
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15) | 2 |
| Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1) | 5 |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 1) | 7 |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 15) | 5 |
| Part A Cohort A1 (Participant Responses - Cycle 2 Day 1) | 6 |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1) | 6 |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15) | 4 |
| Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1) | 7 |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 1) | 10 |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 15) | 8 |
| Part A Cohort A-1(Participant Responses - Cycle 2 Day 1) | 8 |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1) | 2 |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15) | 1 |
| Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1) | 1 |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 1) | 2 |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 15) | 1 |
| Part B Cohort B1 (Participant Responses - Cycle 2 Day 1) | 2 |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1) | 5 |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15) | 4 |
| Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1) | 4 |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 1) | 6 |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 15) | 6 |
| Part B Cohort B2 (Participant Responses - Cycle 2 Day 1) | 6 |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1) | 1 |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15) | 1 |
| Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1) | 1 |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 1) | 3 |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 15) | 3 |
| Part B Cohort B3 (Participant Responses - Cycle 2 Day 1) | 3 |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1) | 6 |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15) | 7 |
| Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1) | 4 |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 1) | 9 |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 15) | 9 |
| Part B Cohort B5 (Participant Responses - Cycle 2 Day 1) | 9 |
Reported measurements
Source class 1
Very easy to swallow tablet
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 15) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 2 Day 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1) | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1) | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 1) | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 15) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 2 Day 1) | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 2 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 1) | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 15) | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 2 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 15) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 2 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15) | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 1) | 6 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 15) | 8 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 2 Day 1) | 9 | Not reported | Not reported | Not reported | Not reported |
Easy to swallow tablet
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 2 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 15) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 2 Day 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 2 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
Neither easy nor difficult to swallow tablet
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 2 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 15) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
Difficult to swallow tablet
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 2 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
Very difficult to swallow tablet
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A1 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A Cohort A-1(Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B1 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B2 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B3 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Caregiver Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 1 Day 15) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B Cohort B5 (Participant Responses - Cycle 2 Day 1) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 5
- title
- Very easy to swallow tablet
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- title
- Easy to swallow tablet
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- title
- Neither easy nor difficult to swallow tablet
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Difficult to swallow tablet
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Very difficult to swallow tablet
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 10
- group Id
- OG010
- value
- 8
- group Id
- OG011
- value
- 8
- units
- Participants
- description
- Participants were evaluated for abemaciclib acceptability (palatability and ease of administration) by asking a question - " Was it easy or difficult for the study subject to swallow the abemaciclib today?" Participants or their caregivers or both could respond using the following possible answers: Very difficult, difficult, neither easy nor difficult, easy, or very easy.
- groups
- description
- Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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 A Cohort A1 (Caregiver Responses - Cycle 1 Day 1)
- description
- Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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
- OG001
- title
- Part A Cohort A1 (Caregiver Responses - Cycle 1 Day 15)
- description
- Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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
- OG002
- title
- Part A Cohort A1 (Caregiver Responses - Cycle 2 Day 1)
- description
- Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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
- OG003
- title
- Part A Cohort A1 (Participant Responses - Cycle 1 Day 1)
- description
- Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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
- OG004
- title
- Part A Cohort A1 (Participant Responses - Cycle 1 Day 15)
- description
- Participants received: * Abemaciclib: 70 milligrams per meters squared (mg/m²), administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered intravenously (IV) on Days 1-5 of each cycle. * Temozolomide: 100 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
- OG005
- title
- Part A Cohort A1 (Participant Responses - Cycle 2 Day 1)
- 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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG006
- title
- Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 1)
- 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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG007
- title
- Part A Cohort A-1(Caregiver Responses - Cycle 1 Day 15)
- 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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG008
- title
- Part A Cohort A-1(Caregiver Responses - Cycle 2 Day 1)
- 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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG009
- title
- Part A Cohort A-1(Participant Responses - Cycle 1 Day 1)
- 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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG010
- title
- Part A Cohort A-1(Participant Responses - Cycle 1 Day 15)
- 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. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG011
- title
- Part A Cohort A-1(Participant Responses - Cycle 2 Day 1)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants in Parts A and B, who received at least one dose of abemaciclib and had evaluable data for this outcome. Per protocol, data were summarized by responses provided by participants, and/or caregivers on the acceptability of the abemaciclib received on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (21 Day Cycles)
- title
- Abemaciclib Tablet Acceptability
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice