Talazoparib + Enzalutamide for Prostate Cancer
(TALAPRO-2 Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use potent P-gp inhibitors within 7 days before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Talazoparib and Enzalutamide for prostate cancer?
Research shows that combining Talazoparib, a PARP inhibitor, with Enzalutamide, an androgen receptor blocker, may improve treatment outcomes for men with metastatic castration-resistant prostate cancer. This combination has shown potential in delaying disease progression compared to using Enzalutamide alone.12345
Is the combination of Talazoparib and Enzalutamide safe for humans?
Enzalutamide, used for prostate cancer, has been generally well-tolerated in clinical trials, but some patients have experienced side effects like severe thrombocytopenia (low platelet count) and seizures. In Japanese patients, certain side effects may occur more frequently due to higher drug concentrations in the blood.678910
How is the drug combination of talazoparib and enzalutamide unique for prostate cancer treatment?
What is the purpose of this trial?
This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Men with advanced prostate cancer that's resistant to hormone therapy (mCRPC), not severely symptomatic, and have a life expectancy of at least 12 months. Participants must have rising PSA levels, be able to swallow pills, consent to genetic testing, and use effective contraception. Excluded are those who've had seizures, significant heart disease, recent opioid treatment for cancer pain or certain prior cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety and PK Run-in
Open-label, non-randomized study to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and pharmacokinetics
Treatment
Randomized, double-blind, placebo-controlled study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enzalutamide
- Talazoparib
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy