Metastatic Castration-resistant Prostate Cancer
Conditions
Brief summary
* Part1: • Occurrence of target safety events., *Part 2: • BICR assessed rPFS per RECIST 1.1 (soft tissue disease) and PCWG3 (bone disease) in participants with mCRPC unselected for DDR status., *Part 2: • BICR assessed rPFS per RECIST 1.1 (soft tissue disease) and PCWG3 (bone disease) in participants with mCRPC harboring DDR deficiencies.
Detailed description
*Part1: • Multiple dose PK parameters of talazoparib and enzalutamide and its N desmethyl metabolite (Multiple dose Cmax, Ctrough, Tmax, AUC and CL/F as data permit)., *Part 2: • OS in participants with mCRPC unselected for DDR status (alpha protected)., *Part 2:• OS participants with mCRPC harboring DDR deficiencies (alpha protected).
Interventions
DRUGTALAZOPARIB
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Part1: • Occurrence of target safety events., *Part 2: • BICR assessed rPFS per RECIST 1.1 (soft tissue disease) and PCWG3 (bone disease) in participants with mCRPC unselected for DDR status., *Part 2: • BICR assessed rPFS per RECIST 1.1 (soft tissue disease) and PCWG3 (bone disease) in participants with mCRPC harboring DDR deficiencies. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Part1: • Multiple dose PK parameters of talazoparib and enzalutamide and its N desmethyl metabolite (Multiple dose Cmax, Ctrough, Tmax, AUC and CL/F as data permit)., *Part 2: • OS in participants with mCRPC unselected for DDR status (alpha protected)., *Part 2:• OS participants with mCRPC harboring DDR deficiencies (alpha protected). | — |
Countries
Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Norway, Poland, Portugal, Spain, Sweden
Outcome results
None listed