A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
NCT ID: NCT04179864
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
102 participants
INTERVENTIONAL
2019-11-18
2024-11-04
Brief Summary
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This study is designed to determine the recommended phase 2 doses (RP2D) of tazemetostat in combination with either enzalutamide or abiraterone/prednisone, based on safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy profiles.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b: Tazemetostat in Combination with Abiraterone/Prednisone
In Phase 1b, abiraterone/prednisone will be administered in combination with tazemetostat in cycle 1 (28 days) to establish the recommended dose of tazemetostat in this combination; participants may continue treatment in additional 28-day cycles, as tolerated, until progression or unacceptable toxicity
Tazemetostat
Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
Abiraterone/prednisone
1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily in combination with prednisone 5 mg administered orally twice daily.
Phase 1b: Tazemetostat in Combination with Enzalutamide
In Phase 1b, enzalutamide will be administered in combination with tazemetostat in cycle 1 (28 days) to establish the recommended dose of tazemetostat in this combination; participants may continue treatment in additional 28-day cycles, as tolerated, until progression or unacceptable toxicity
Tazemetostat
Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
Enzalutamide
enzalutamide 160 mg (four 40 mg capsules) orally once daily
Phase 2: Tazemetostat in Combination with Enzalutamide
Participants will receive the newly established recommended phase 2 dose, orally twice daily when given in combination with enzalutamide) as determined in phase 1b part of the study) or enzalutamide alone.
All participants will receive treatment in 28-day cycles.
Tazemetostat
Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
Enzalutamide
enzalutamide 160 mg (four 40 mg capsules) orally once daily
Phase 2: Enzalutamide only
In Phase 2, Enzalutamide will be administered on cycle 1 day 1
Enzalutamide
enzalutamide 160 mg (four 40 mg capsules) orally once daily
Interventions
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Tazemetostat
Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
Abiraterone/prednisone
1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily in combination with prednisone 5 mg administered orally twice daily.
Enzalutamide
enzalutamide 160 mg (four 40 mg capsules) orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix
3. Life expectancy of \> 3 months.
4. Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
5. 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.
6. 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.
7. 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.
* 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.
3. Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment
4. Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.
Exclusion Criteria
2. 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.
18 Years
MALE
No
Sponsors
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Epizyme, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Genesis Healthcare Partners
San Diego, California, United States
The Urology Center Of Colorado
Denver, Colorado, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
XCancer - Northwest Oncology and Hematology
Rolling Meadows, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Associated Medical Professionals of NY, PLLC - Urology
Syracuse, New York, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
SCRI - Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Urology Associates P.C.
Hendersonville, Tennessee, United States
XCancer - Tennesee Cancer Specialists
Knoxville, Tennessee, United States
SCRI - Tennessee Oncology Nashville
Nashville, Tennessee, United States
Urology San Antonio
San Antonio, Texas, 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
Countries
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Other Identifiers
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2019-003649-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EZH-1101
Identifier Type: -
Identifier Source: org_study_id