TriangleNCT03395197 · OUTCOME
Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
What was measured
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by computed tomography (CT) of chest and CT or magnetic resonance imaging (MRI) of abdomen and pelvis. Progression is defined using RECIST 1.1 as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results as of 16 Aug 2022 are reported for this outcome measure.
Analysis population: Included all participants randomized to double-blind study treatment in Part 2 Cohort 1 regardless of whether or not treatment was administered.
Groups in this outcome
Part 2 Cohort 1: Talazoparib+Enzalutamide
Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
Part 2 Cohort 1: Placebo+Enzalutamide
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
| Group | Source count |
|---|---|
| Part 2 Cohort 1: Talazoparib+Enzalutamide | 402 |
| Part 2 Cohort 1: Placebo+Enzalutamide | 403 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 Cohort 1: Talazoparib+Enzalutamide | NA | Not reported | 27.5 | NA | NA indicates not estimated due to less than half of participants meeting the criterion as of data cutoff date (16 Aug 2022). |
| Part 2 Cohort 1: Placebo+Enzalutamide | 21.9 | Not reported | 16.6 | 25.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.506
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.777
- estimate Comment
- Hazard ratio was based on Cox proportional hazards model; under proportional hazards, if hazard ratio \< 1, it indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.
- group Description
- The following statistical hypotheses was tested to address the primary objectives: H01: HRrPFS ≥1 vs H11: HRrPFS \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the all-comers population for Part 2 Cohort 1.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- 1-sided
- param Type
- Hazard Ratio (HR)
- param Value
- 0.627
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.506
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.777
- estimate Comment
- Hazard ratio was based on Cox proportional hazards model; under proportional hazards, if hazard ratio \< 1, it indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.
- group Description
- The following statistical hypotheses was tested to address the primary objectives: H01: HRrPFS ≥1 vs H11: HRrPFS \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the all-comers population for Part 2 Cohort 1.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- 1-sided
- param Type
- Hazard Ratio (HR)
- param Value
- 0.627
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA indicates not estimated due to less than half of participants meeting the criterion as of data cutoff date (16 Aug 2022).
- group Id
- OG000
- lower Limit
- 27.5
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 16.6
- upper Limit
- 25.1
- value
- 21.9
- denoms
- counts
- group Id
- OG000
- value
- 402
- group Id
- OG001
- value
- 403
- units
- Participants
- description
- rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by computed tomography (CT) of chest and CT or magnetic resonance imaging (MRI) of abdomen and pelvis. Progression is defined using RECIST 1.1 as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results as of 16 Aug 2022 are reported for this outcome measure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
- id
- OG000
- title
- Part 2 Cohort 1: Talazoparib+Enzalutamide
- description
- Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
- id
- OG001
- title
- Part 2 Cohort 1: Placebo+Enzalutamide
- param Type
- MEDIAN
- population Description
- Included all participants randomized to double-blind study treatment in Part 2 Cohort 1 regardless of whether or not treatment was administered.
- reporting Status
- POSTED
- time Frame
- From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
- title
- Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice