🏛️ Verified NIH Record • Updated 2026-05-08

Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC (NCT04846478)

A Phase Ia/Ib Study of Talazoparib in Combination With Tazemetostat in Metastatic Castration-resistant Prostate Cancer (mCRPC)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Dana-Farber Cancer Institute

🩺 Plain-English Summary (8th-Grade Level)

This trial is testing whether molecularly targeted oral medications called talazoparib and tazemetostat can be safely combined for the treatment of prostate cancer, and whether the combination is effective in shrinking or preventing the growth of metastatic prostate cancer. The names of the study drugs involved in this study are: * Talazoparib * Tazemetostat

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (32 items) and avoid the listed exclusions (18 items).

Location: Brigham and Women's Hospital — Boston, Massachusetts

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants who have had chemotherapy, intravenous experimental agent, radiopharmaceutical therapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
  • Participants who have received oral anti-neoplastic intervention such as an oral hormonal agent, PARP inhibitor, or oral experimental agent within 14 days prior to planned cycle 1 day 1 of study treatment.
  • Participants who have not recovered from clinically significant adverse events due to prior anti-cancer therapy (i.e., have clinically significant residual toxicities \> Grade 1) except for stable complications of prior procedures (such as urinary incontinence or erectile dysfunction) or Grade 2 anorexia, alopecia, neuropathy, and fatigue, for which resolution is not required.
  • Participants who are receiving any other investigational agents.
  • Participants previously treated with an inhibitor of EZH2.
  • Patients with known brain metastases or leptomeningeal disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to talazoparib or tazemetostat.
  • Participants receiving the following concurrent medications:
  • Participants receiving the P-gp inhibitors amiodarone, carvedilol, clarithromycin, itraconazole, or verapamil are ineligible. Participants receiving other P-gp inhibitors are not excluded but should be monitored for potential increased adverse reactions.
  • Participants receiving BCRP inhibitors are not excluded but should be monitored for potential increased adverse reactions.
  • Participants receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP3A4 are ineligible.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Brigham and Women's Hospital — Boston, Massachusetts
  • Dana Farber Cancer Institute — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗