An Early Phase 1 interventional study of Tazverik in Prostate Cancer, sponsored by Edwin Posadas, MD. Withdrawn at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Edwin Posadas, MD · Early Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Concurrent use of strong and moderate CYP3A inhibitors and inducers
Tazemetostat 200 mg oral tablets; 800 mg by mouth twice daily for 28 days
Drug: Tazverik
Tazemetostat (Tazverik) 200 mg oral tablets; 800 mg by mouth twice daily for 28 days
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.
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.
Proportion of patients able to undergo surgery
Time frame: 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.
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.
Proportion of patients with evaluable tissue specimens following tazemetostat
Time frame: At time of surgery
Clinical Progression Free Survival
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.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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