Talazoparib + Tazemetostat for Prostate Cancer

Recruiting at1 trial location

Overseen by Atish D. Choudhury

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Atish D. Choudhury

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adult men with advanced prostate cancer that has spread and is worsening, despite previous hormone therapy. They must be able to swallow pills, have good organ function, agree to use contraception, and undergo a biopsy for genetic testing. Men with HIV or hepatitis can join if well-controlled. Excluded are those on certain other drugs, with recent thrombosis, uncontrolled illnesses, brain metastases or another active cancer.

Inclusion Criteria

I am mostly able to carry out my daily activities.

I have been treated with a PARP inhibitor before.

My heart function is classified as class 2B or better according to the NYHA.

Exclusion Criteria

I haven't had chemotherapy, experimental treatments, or radiotherapy in the last 4 weeks.

I haven't taken any cancer pills like hormone therapy or experimental drugs in the last 14 days.

I do not have brain metastases or leptomeningeal disease.

Treatment Details

Interventions

• Talazoparib (PARP Inhibitor)
• Tazemetostat (Histone Methyltransferase Inhibitor)

Trial Overview The trial tests combining talazoparib and tazemetostat—oral medications targeting specific molecular pathways in prostate cancer cells—to see if they're safe together and effective against metastatic prostate cancer.

Participant Groups

Group I: Dose Expansion Talazoparib + Tazemetostat Experimental Treatment 2 Interventions

Participants will receive talazoparib and tazemetostat at the safe dose identified in the first part (dose escalation) of the study. During each 28 day study treatment cycle participants will take: * Talazoparib once daily. * Tazemetostat twice daily.

Group II: Dose Escalation Talazoparib + Tazemetostat Experimental Treatment 2 Interventions

Standard 3+3 dose escalation will be followed, participants will initially receive talazoparib and tazemetostat at a dose of 75% of the starting dose for their FDA-approved indications. During each 28 day study treatment cycle participants will take: * Talazoparib once daily. * Tazemetostat twice daily.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Epizyme, Inc.

Industry Sponsor

Trials

34

Recruited

2,800+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

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