A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
Public ClinicalTrials.gov record NCT04179864. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination With Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naive Subjects With Metastatic Castration-Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a global, multi-center, open-label, randomized phase 1b/2, active-controlled safety and efficacy study of oral administration of tazemetostat in combination with enzalutamide or abiraterone/prednisone (phase 1b) versus enzalutamide or abiraterone/prednisone alone in asymptomatic or mildly symptomatic subjects with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have progressed on either abiraterone acetate, enzalutamide, or apalutamide or who are second generation anti-androgen treatment naive, and who have not received chemotherapy for mCRPC. 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.
Study identification
- NCT ID
- NCT04179864
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 102 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2019 (Actual)
- Primary completion
- Nov 4, 2024 (Actual)
- Completion
- Nov 4, 2024 (Actual)
- Last update posted
- Mar 10, 2026
2019 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Genesis Healthcare Partners | San Diego | California | 92123 | — |
| The Urology Center Of Colorado | Denver | Colorado | 80211 | — |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| XCancer - Northwest Oncology and Hematology | Rolling Meadows | Illinois | 60008 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | 89169 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Associated Medical Professionals of NY, PLLC - Urology | Syracuse | New York | 13210 | — |
| Montefiore Einstein Center for Cancer Care | The Bronx | New York | 10461 | — |
| University of Pittsburgh Medical Center - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| SCRI - Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | — |
| Urology Associates P.C. | Hendersonville | Tennessee | 37075 | — |
| XCancer - Tennesee Cancer Specialists | Knoxville | Tennessee | 37909 | — |
| SCRI - Tennessee Oncology Nashville | Nashville | Tennessee | 37203 | — |
| Urology San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04179864, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 10, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04179864 live on ClinicalTrials.gov.