Study on the Safety and Tolerability of BMS-986158 Alone and with Ruxolitinib or Fedratinib for Blood Cancer (Myelofibrosis)
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT04817007
This clinical trial is testing the safety and tolerability of a new drug, BMS-986158, used alone or in combination with either Ruxolitinib or Fedratinib, in patients with certain types of blood cancer, specifically myelofibrosis.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to evaluate how safe and tolerable the drug BMS-986158 is when used by itself or together with either Ruxolitinib or Fedratinib in patients with intermediate or high-risk myelofibrosis, a type of blood cancer. The study is divided into two parts: Part 1 involves testing BMS-986158 with either Ruxolitinib or Fedratinib, and Part 2 involves testing BMS-986158 both alone and in combination with these drugs.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with primary myelofibrosis (PMF), or myelofibrosis that developed after essential thrombocythemia (ET) or polycythemia vera (PV).
- Any side effects from previous treatments must have improved to a mild level or returned to what they were before treatment, unless they are considered permanent.
- Must agree to use specific methods of birth control, if applicable.
Exclusion Criteria
- Women who are pregnant or breastfeeding at the time of screening.
- Any serious or uncontrolled ongoing medical conditions.
Other specific criteria may 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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