TriangleNCT04238819 · OUTCOME
Percentage of Participants With Overall Response Rate (ORR): Part A
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 disease progression or death (Up to 25 Months)
What was measured
ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO). 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).
Analysis population: All participants in Part A 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 A Cohort A1
Participants received: * Abemaciclib: 70 mg/m², administered orally twice daily (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
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.
| Group | Source count |
|---|---|
| Part A Cohort A1 | 7 |
| Part A Cohort A-1 | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Cohort A1 | 0 | Not reported | NA | NA | None of the participants achieved ORR. Thus, upper and lower limit of confidence interval values could not be calculated. |
| Part A Cohort A-1 | 7.7 | Not reported | 0.0 | 22.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- None of the participants achieved ORR. Thus, upper and lower limit of confidence interval values could not be calculated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 22.2
- value
- 7.7
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO). 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).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received: * Abemaciclib: 70 mg/m², administered orally twice daily (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
- OG000
- title
- Part A Cohort A1
- 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
- OG001
- title
- Part A Cohort A-1
- param Type
- NUMBER
- population Description
- All participants in Part A 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 disease progression or death (Up to 25 Months)
- title
- Percentage of Participants With Overall Response Rate (ORR): Part A
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice