TriangleNCT04238819 · OUTCOME
Percentage of Participants With DCR: Part B
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Date of first dose to measured progressive disease (Up to 25 Months)
What was measured
DCR: Percentage of participants with a best overall response of CR, PR, and SD. RECIST was used for solid tumors and RANO was used for brain tumors. * CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO). * PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and \>50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO). * SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
Analysis population: All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
Groups in this outcome
Part B Cohort B1
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
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
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
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 B Cohort B1 | 3 |
| Part B Cohort B2 | 9 |
| Part B Cohort B3 | 3 |
| Part B Cohort B5 | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B Cohort B1 | 33.3 | Not reported | 0.0 | 86.7 | Not reported |
| Part B Cohort B2 | 55.6 | Not reported | 23.1 | 88.0 | Not reported |
| Part B Cohort B3 | 100 | Not reported | 100.0 | 100.0 | Not reported |
| Part B Cohort B5 | 36.4 | Not reported | 7.9 | 64.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 86.7
- value
- 33.3
- group Id
- OG001
- lower Limit
- 23.1
- upper Limit
- 88.0
- value
- 55.6
- group Id
- OG002
- lower Limit
- 100.0
- upper Limit
- 100.0
- value
- 100
- group Id
- OG003
- lower Limit
- 7.9
- upper Limit
- 64.8
- value
- 36.4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 11
- units
- Participants
- description
- DCR: Percentage of participants with a best overall response of CR, PR, and SD. RECIST was used for solid tumors and RANO was used for brain tumors. * CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO). * PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and \>50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO). * SD is neither sufficient shrinkage nor sufficient increase in the size of the tumor.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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.
- id
- OG000
- title
- Part B Cohort B1
- description
- 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.
- id
- OG001
- title
- Part B Cohort B2
- description
- 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.
- id
- OG002
- title
- Part B Cohort B3
- description
- 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.
- id
- OG003
- title
- Part B Cohort B5
- param Type
- NUMBER
- population Description
- All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
- reporting Status
- POSTED
- time Frame
- Date of first dose to measured progressive disease (Up to 25 Months)
- title
- Percentage of Participants With DCR: Part B
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice