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  • NCT04817007

Active, Not Recruiting

A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) - CA011-023

Updated: 11 March, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A: BMS-986158 + Ruxolitinib
Drug: Ruxolitinib, BMS-986158
Experimental: Part 1B: BMS-986158 + Fedratinib
Drug: BMS-986158, Fedratinib
Experimental: Part 2A1: BMS-986158 + Ruxolitinib
Drug: Ruxolitinib, BMS-986158
Experimental: Part 2A2 Add-On: BMS-986158 + Ruxolitinib
Drug: Ruxolitinib, BMS-986158
Experimental: Part 2A3: BMS-986158 + Ruxolitinib
Drug: Ruxolitinib, BMS-986158
Experimental: Part 2B1: BMS-986158 + Fedratinib
Drug: Fedratinib, BMS-986158
Experimental: Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

Key Eligibility Criteria

Inclusion Criteria: - Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis - Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment - Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Women who are pregnant or breastfeeding at screening - Any significant acute or uncontrolled chronic medical illness Other protocol-defined inclusion/exclusion criteria apply

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Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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