A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer

NCT ID: NCT05567679

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

Brief Summary

This study is an open-label, single-arm, pilot, perioperative study of EZH2 inhibition in patients undergoing Radical Prostatectomy (RP). The EZH2 inhibition is intended to increase the sensitivity of the underlying tumor to the patient's immune system.

Given the absence of data in this setting, we propose to pilot this experience with 4 weeks of tazemetostat at doses known to be clinically safe and effective at inducing clinical effects via inhibition of EZH2 as established for follicular lymphoma and epithelioid sarcoma: 800 mg twice daily with or without food.

Prior to tazemetostat, blood will be collected (4 tubes) for immune cells, Circulating Tumor Cells, and plasma. This will be repeated at the time of RP. RP tissues will be collected.

Additionally, patients will have a week lead-in to wear a FitBit Charge 5TM device (or similar model) to continuously monitor physical activity from baseline up until end of study. The start of the week lead-in will be considered the baseline visit. Subjects will also be asked to continue wearing the device until end of study and option to continue for up to 2 years after end of study in follow-up.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tazemetostat

Tazemetostat 200 mg oral tablets; 800 mg by mouth twice daily for 28 days

Group Type: EXPERIMENTAL

Tazverik

Intervention Type: DRUG

Tazemetostat (Tazverik) 200 mg oral tablets; 800 mg by mouth twice daily for 28 days

Interventions

Tazverik

Tazemetostat (Tazverik) 200 mg oral tablets; 800 mg by mouth twice daily for 28 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men electing to undergo radical prostatectomy with preoperative tissue available
• Able to take oral medications
• Age ≥18 years
• Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Adequate organ function
• Men with partners of childbearing potential, must have had a successful vasectomy (with medically confirmed lack of sperm that are alive) OR must either practice complete abstinence or agree to use adequate contraception

Exclusion Criteria

• Active intercurrent illness or malignancy requiring therapy outside of prostate cancer
• History of bleeding disorders
• Concurrent use of anti-platelet agents or therapeutic anticoagulants with the exception of low-dose aspirin (81 mg daily) or NSAIDs for pain/inflammation.

Concurrent use of strong and moderate CYP3A inhibitors and inducers

• Subjects who have previously received tazemetostat
• Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of tazemetostat

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Epizyme, Inc.

INDUSTRY

Sponsor Role: collaborator

Edwin Posadas, MD

OTHER

Sponsor Role: lead

Responsible Party

Edwin Posadas, MD

Co-Director, Experimental Therapeutics Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edwin Posadas, MD FACP

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

IIT2021-09-Posadas-NA-TAZ

Identifier Type: -

Identifier Source: org_study_id