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

NCT05567679 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: IIT2021-09-Posadas-NA-TAZ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate cancer; Radical prostatectomy; RP

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events, serious adverse events, and treatment-related adverse events.

  Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  From start of study treatment until confirmation of disease progression, intolerable toxicities, or withdrawal of consent, whichever came first. Assessed up to 30 days following last dose of study treatment.

• Proportion of patients able to undergo surgery

  At time of surgery

• Proportion of patients with Grade 3 or above treatment related adverse events

  Grade 3 or above treatment related adverse events as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  From start of study treatment until confirmation of disease progression, intolerable toxicities, or withdrawal of consent, whichever came first. Assessed up to 30 days following last dose of study treatment.

• Proportion of patients with evaluable tissue specimens following tazemetostat

  At time of surgery

Secondary Outcomes (1)

• Clinical Progression Free Survival

  From the start of study treatment until documented progression, or death due to any cause. Assessed up to 5 years.

Study Arms (1)

Tazemetostat

EXPERIMENTAL

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

Drug: Tazverik

Interventions

Tazverik DRUG

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

Tazemetostat

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwin Posadas, MD: lead
• Epizyme, Inc.: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tazemetostat

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Edwin Posadas, MD FACP

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director, Experimental Therapeutics Program

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 5, 2022
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)