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)
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT04817007
This study evaluates the safety, tolerability, and efficacy of BMS-986158, alone or with Ruxolitinib or Fedratinib, in DIPSS-intermediate/high-risk myelofibrosis patients. Eligible participants include those with PMF, post-ET, or post-PV myelofibrosis, with resolved treatment-related toxicities. Interventions involve specified doses of BMS-986158, Ruxolitinib, and Fedratinib.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0069 | 92663 | Newport Beach | California |
| Local Institution - 0090 | 32746 | Lake Mary | Florida |
| Local Institution - 0043 | 70112 | New Orleans | Louisiana |
| Local Institution - 0038 | 01655 | Worcester | Massachusetts |
| Local Institution - 0033 | 48109 | Ann Arbor | Michigan |
| Local Institution - 0045 | 07601 | Hackensack | New Jersey |
| Local Institution - 0076 | 27514 | Chapel Hill | North Carolina |
| Local Institution - 0042 | 15224 | Pittsburgh | Pennsylvania |
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