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)

Part of paid clinical trials in Newport Beach, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04817007
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986158 — DRUG
    Specified dose on specified days
  • Ruxolitinib — DRUG
    Specified dose on specified days
  • Fedratinib — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

Key Dates

Start date
Mar 22, 2021
Status verified
Feb 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 52 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Local Institution - 0069Newport BeachCalifornia92663-
Local Institution - 0090Lake MaryFlorida32746-
Local Institution - 0043New OrleansLouisiana70112-
Local Institution - 0038WorcesterMassachusetts01655-
Local Institution - 0033Ann ArborMichigan48109-
Local Institution - 0045HackensackNew Jersey07601-
Local Institution - 0076Chapel HillNorth Carolina27514-
Local Institution - 0042PittsburghPennsylvania15224-

Find similar trials in Newport Beach, CA

By research site
Local Institution - 0069· Newport Beach, CALocal Institution - 0090· Lake Mary, FLLocal Institution - 0043· New Orleans, LALocal Institution - 0038· Worcester, MALocal Institution - 0033· Ann Arbor, MILocal Institution - 0045· Hackensack, NJ

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