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

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tazverik
Sponsored by
Edwin Posadas, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Radical prostatectomy, RP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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
  • Inclusion criteria for remote monitoring component of study with Fitbit only (failure to meet inclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Access to a device (e.g., smart phone, tablet) that has the capability to sync to the Fitbit. Note: access can be via family member, friend, caregiver, or study-designated device provided by study member

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
  • Exclusion criteria for remote monitoring component of study with Fitbit only (failure to meet exclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, per PI's discretion.

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tazemetostat

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Proportion of patients able to undergo 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.
Proportion of patients with evaluable tissue specimens following tazemetostat

Secondary Outcome Measures

Clinical Progression Free Survival
Defined by a detectable post-operative prostate-specific antigen (PSA)

Full Information

First Posted
September 28, 2022
Last Updated
September 21, 2023
Sponsor
Edwin Posadas, MD
Collaborators
Epizyme, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05567679
Brief Title
A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer
Official Title
IIT2021-09-Posadas-NA-TAZ: A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI voluntarily closed the study.
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edwin Posadas, MD
Collaborators
Epizyme, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Radical prostatectomy, RP

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tazemetostat
Arm Type
Experimental
Arm Description
Tazemetostat 200 mg oral tablets; 800 mg by mouth twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Tazverik
Intervention Description
Tazemetostat (Tazverik) 200 mg oral tablets; 800 mg by mouth twice daily for 28 days
Primary Outcome Measure Information:
Title
Incidence of adverse events, serious adverse events, and treatment-related adverse events.
Description
Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
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.
Title
Proportion of patients able to undergo surgery
Time Frame
At time of surgery
Title
Proportion of patients with Grade 3 or above treatment related adverse events
Description
Grade 3 or above treatment related adverse events as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
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.
Title
Proportion of patients with evaluable tissue specimens following tazemetostat
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Clinical Progression Free Survival
Description
Defined by a detectable post-operative prostate-specific antigen (PSA)
Time Frame
From the start of study treatment until documented progression, or death due to any cause. Assessed up to 5 years.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Inclusion criteria for remote monitoring component of study with Fitbit only (failure to meet inclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Access to a device (e.g., smart phone, tablet) that has the capability to sync to the Fitbit. Note: access can be via family member, friend, caregiver, or study-designated device provided by study member 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 Exclusion criteria for remote monitoring component of study with Fitbit only (failure to meet exclusion criterion for Fitbit-monitoring portion of study should not preclude participating in treatment trial): Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, per PI's discretion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Posadas, MD FACP
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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