A Randomized Open-label Phase 2 Study of TALazoparib With or Without ENzaluTamide in Patients With Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate
Prostate Cancer Clinical Trials Consortium
Summary
The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria • Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: Privacy authorization may be either included in the informed consent or obtained separately. * Participants ≥ 18 years of age. * Are willing to be randomized into either study arm and adhere to the study protocol. * Ability to swallow study capsules and/or tablets whole. * Are willing to remain on stud…
Interventions
- DrugTalazoparib with enzalutamide
Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles.
- DrugTalazoparib
Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles.
Locations (2)
- Dana Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York