Prostate Cancer Clinical Trial

A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer

Summary

A phase 1b/2 study to examine taz in combination with enz or abi/pred in patients with metastatic castration resistant prostate cancer

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age at the time of consent ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix
Life expectancy of > 3 months.
Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.

Progressive disease in the setting of medical or surgical castration (ie, castration- resistant prostate cancer [CRPC]) by PCWG3 criteria for study entry.

Evidence of disease progression by rising PSA or
Soft tissue progression per RECIST 1.1 or
Evidence of disease progression by observation of 2 new bone lesions since the initiation of last systemic therapy.

Metastatic prostate cancer disease, documented by the following imaging

• Bone lesions on bone scan (per PCWG3) or by soft tissue disease (per RECIST 1.1) by CT/MRI imaging Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist.

Prior treatment with a second-generation androgen inhibitor as follows:

For phase 1b, EITHER Previously untreated with or progressed on a second generation androgen inhibitor (abiraterone, enzalutamide, or apalutamide) OR progressed on a second generation inhibitor (inhibitor (abiraterone, enzalutamide, or apalutamide)
For phase 2 randomized component (i.e, enzalutamide- containing treatment arms) of the study, previously progressed on abiraterone.

Exclusion Criteria:

Known symptomatic brain metastases

Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of starting study treatment:

First generation: AR antagonists (eg, bicalutamide, nilutamide, flutamide) within 4 weeks.
5-alpha-reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol), or progesterones within 2 weeks.
Chemotherapy (except as permitted in inclusion criteria #10) within 3 weeks.
Prior radionuclide therapy within 4 weeks.
Another interventional product or standard agent in a clinical study within 28 days prior to the first planned dose of Tazemetostat
For phase 2 subjects to be randomized to one of the enzalutamide treatment arms only, prior treatment with the second-generation androgen antagonist including enzalutamide, apalutamide, darolutamide, and proxalutamide, etc.
Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment
Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

102

Study ID:

NCT04179864

Recruitment Status:

Active, not recruiting

Sponsor:

Epizyme, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 16 Locations for this study

See Locations Near You

Genesis Healthcare Partners
San Diego California, 92123, United States
The Urology Center Of Colorado
Denver Colorado, 80211, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie Florida, 34952, United States
XCancer - Northwest Oncology and Hematology
Rolling Meadows Illinois, 60008, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas Nevada, 89169, United States
Montefiore Einstein Center for Cancer Care
Bronx New York, 10461, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Associated Medical Professionals of NY, PLLC - Urology
Syracuse New York, 13210, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
SCRI - Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Urology Associates P.C.
Hendersonville Tennessee, 37075, United States
XCancer - Tennesee Cancer Specialists
Knoxville Tennessee, 37909, United States
SCRI - Tennessee Oncology Nashville
Nashville Tennessee, 37203, United States
Urology San Antonio
San Antonio Texas, 78229, United States
Academisch Ziekenhuis Groeninge Campus Kennedylaan
Kortrijk West Vlaanderen, , Belgium
Hospital Universitario de Jerez de la Frontera
Jerez De La Frontera Cadiz, , Spain
Hospital de la Santa Creu i. Sant Pau
Barcelona , , Spain
Hospital del Mar Parc de Salut Mar
Barcelona , , Spain
Hospital Clinico San Carlos
Madrid , , Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitario La Paz
Madrid , , Spain
Clinica Universidad de Navarra
Pamplona , , Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

102

Study ID:

NCT04179864

Recruitment Status:

Active, not recruiting

Sponsor:


Epizyme, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.