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NCT04603495 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
A Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 430
- Enrollment target
- 20
- Study locations
NCT04603495 is a Phase 3 study of Myelofibrosis and Primary Myelofibrosis that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 430 participants, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (128% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT04603495, a Phase 3 study of Myelofibrosis and Primary Myelofibrosis, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 430 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pelabresib
- DRUG Ruxolitinib
Study Locations (20)
California
- UC San Diego Moores Cancer Center - La Jolla
- USC/Norris Comprehensive Cancer Center - Los Angeles
- UCLA Medical Center - Los Angeles
New York
- Icahn School of Medicine at Mount Sinai - New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical College- New York Presbyterian Hospital - New York
Florida
- Mayo Clinic - Jacksonville
- Moffitt Cancer Center - Tampa
Texas
- MD Anderson Cancer Center - Houston
- University of Texas Health Science Center - San Antonio - San Antonio
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Chandler
Connecticut
- Yale University School of Medicine - New Haven
Illinois
- Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04603495
The ClinicalTrials.gov registry entry for NCT04603495 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (128% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04603495 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT04603495 about?
NCT04603495 is a clinical study titled "Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)". A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET)...
What is the current status of trial NCT04603495?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 430 participants. The study started on 2021-04-09. Estimated completion is 2027-06-30.
What conditions does trial NCT04603495 study?
This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis.
What interventions are being tested in trial NCT04603495?
The interventions under investigation include: Placebo (DRUG), Pelabresib (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04603495?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04603495 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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