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PARP Inhibitor

Talazoparib + Tazemetostat for Prostate Cancer

Phase 1

Waitlist Available

Led By Atish Choudhury, MD PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A)

Age ≥18 years. Children under 18 are excluded from this study as prostate cancer is a disease of adults

Must not have

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

Participants previously treated with an inhibitor of EZH2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of combining these two drugs to treat prostate cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of talazoparib include anemia, nausea, fatigue; while tazemetostat may cause tiredness, muscle pain. Both drugs could potentially affect blood counts and liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to carry out my daily activities.

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I am 18 years old or older.

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I agree to use effective birth control during and 6 months after the study.

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I have previously been treated with a newer hormone therapy for my prostate cancer.

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My blood and organ functions meet the required levels for the trial.

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I have prostate cancer with worsening signs, either through rising PSA levels or worsening scans.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have brain metastases or leptomeningeal disease.

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I have been treated with an EZH2 inhibitor before.

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I do not have any uncontrolled illnesses like heart failure or ongoing infections.

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I have had a blood clot in the last 3 months.

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I am not pregnant or nursing, as this study is for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0

Rate of Dose Limiting Toxicity (DLT)

Secondary study objectives

Overall response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion Talazoparib + TazemetostatExperimental Treatment2 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 + TazemetostatExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tazemetostat

2016

Completed Phase 2

~1050

Talazoparib

2021

Completed Phase 2

~2820