Tazemetostat + Hormone Therapy for Advanced Prostate Cancer
(CELLO-1 Trial)

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Epizyme, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a global, multi-center, open-label, randomized phase 1b/2, active-controlled safety and efficacy study of oral administration of tazemetostat in combination with enzalutamide or abiraterone/prednisone (phase 1b) versus enzalutamide or abiraterone/prednisone alone in asymptomatic or mildly symptomatic subjects with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have progressed on either abiraterone acetate, enzalutamide, or apalutamide or who are second generation anti-androgen treatment naive, and who have not received chemotherapy for mCRPC. This study is designed to determine the recommended phase 2 doses (RP2D) of tazemetostat in combination with either enzalutamide or abiraterone/prednisone, based on safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy profiles.

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to castration and has progressed after treatment with certain medications. They should be relatively healthy (ECOG status 0-1) and have a life expectancy of more than 3 months. Men who've had brain metastases, recent other cancer treatments, or previous tazemetostat use are excluded.

Inclusion Criteria

I am fully active or can carry out light work.

My prostate cancer is confirmed by lab tests.

Life expectancy of > 3 months

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Exclusion Criteria

I have previously been treated with tazemetostat or similar medications.

I haven't taken specific prostate cancer treatments recently before starting the study.

I have brain metastases that cause symptoms.

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Treatment Details

Interventions

Abiraterone/prednisone (Hormone Therapy)
Enzalutamide (Hormone Therapy)
Tazemetostat (Epigenetic Modulator)

Trial OverviewThe trial is testing the safety and effectiveness of Tazemetostat combined with either Enzalutamide or Abiraterone/Prednisone in men whose prostate cancer has worsened despite treatment. It aims to find the best doses for phase 2 trials based on various health outcomes.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2: Tazemetostat in Combination with EnzalutamideExperimental Treatment2 Interventions

Participants will receive the newly established recommended phase 2 dose, orally twice daily when given in combination with enzalutamide) as determined in phase 1b part of the study) or enzalutamide alone. All participants will receive treatment in 28-day cycles.

Group II: Phase 1b: Tazemetostat in Combination with EnzalutamideExperimental Treatment2 Interventions

In Phase 1b, enzalutamide will be administered in combination with tazemetostat in cycle 1 (28 days) to establish the recommended dose of tazemetostat in this combination; participants may continue treatment in additional 28-day cycles, as tolerated, until progression or unacceptable toxicity

Group III: Phase 1b: Tazemetostat in Combination with Abiraterone/PrednisoneExperimental Treatment2 Interventions

In Phase 1b, abiraterone/prednisone will be administered in combination with tazemetostat in cycle 1 (28 days) to establish the recommended dose of tazemetostat in this combination; participants may continue treatment in additional 28-day cycles, as tolerated, until progression or unacceptable toxicity

Group IV: Phase 2: Enzalutamide onlyActive Control1 Intervention

In Phase 2, Enzalutamide will be administered on cycle 1 day 1