A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer
Key facts
- Who runs it
- Edwin Posadas, MD
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Early phase 1
- Started
- Dec 2023
- Ended
- Dec 2025
- Type of study
- Interventional
- Treatments tested
- Tazverik
- Record updated
- 22 September 2023
- Why it stopped
- PI voluntarily closed the study.
Who can take part
- Age
- 18 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Active intercurrent illness or malignancy requiring therapy outside of prostate cancer
- History of bleeding disorders
- 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
- 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
Where in United States
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- TazemetostatTreatment being tested
Tazemetostat 200 mg oral tablets; 800 mg by mouth twice daily for 28 days
Treatment: Tazverik
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- IIT2021-09-Posadas-NA-TAZ: A Study of Tazemetostat (Tazverik) Before Prostatectomy in Men With Prostate Cancer
- Record updated
- 22 September 2023