TriangleNCT02952534 · OUTCOME
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)
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
- Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
What was measured
The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: IRR Efficacy Population - The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review.
Groups in this outcome
BRCA Mutation
Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
ATM Mutation
Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
CDK12 Mutation
Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
CHEK2 Mutation
Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
Other Gene Mutation
Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
| Group | Source count |
|---|---|
| BRCA Mutation | 81 |
| ATM Mutation | 23 |
| CDK12 Mutation | 8 |
| CHEK2 Mutation | 4 |
| Other Gene Mutation | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BRCA Mutation | 45.7 | Not reported | 34.6 | 57.1 | Not reported |
| ATM Mutation | 0.0 | Not reported | 0.0 | 14.8 | Not reported |
| CDK12 Mutation | 0.0 | Not reported | 0.0 | 36.9 | Not reported |
| CHEK2 Mutation | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Other Gene Mutation | 41.2 | Not reported | 18.4 | 67.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.6
- upper Limit
- 57.1
- value
- 45.7
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 14.8
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG004
- lower Limit
- 18.4
- upper Limit
- 67.1
- value
- 41.2
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 17
- units
- Participants
- description
- The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
- id
- OG000
- title
- BRCA Mutation
- description
- Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
- id
- OG001
- title
- ATM Mutation
- description
- Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
- id
- OG002
- title
- CDK12 Mutation
- description
- Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
- id
- OG003
- title
- CHEK2 Mutation
- description
- Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
- id
- OG004
- title
- Other Gene Mutation
- param Type
- NUMBER
- population Description
- IRR Efficacy Population - The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review.
- reporting Status
- POSTED
- time Frame
- Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
- title
- Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice