Trials / Recruiting
RecruitingNCT06844383
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- Sponsor
- Prostate Cancer Clinical Trials Consortium · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Talazoparib with enzalutamide | Talazoparib (0.5 mg PO QD) and enzalutamide (160 mg PO QD) will be administered in continuous 28-day cycles. |
| DRUG | Talazoparib | Talazoparib (1 mg PO QD) will be administered in continuous 28-day cycles. |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2029-03-01
- Completion
- 2030-03-01
- First posted
- 2025-02-25
- Last updated
- 2025-10-29
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06844383. Inclusion in this directory is not an endorsement.