drugset / Trial / NCT04817007

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)

NCT04817007

Phase 1/2 Active not recruiting 216 enrolled Bristol-Myers Squibb
RandomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2021-03-22
Primary completion
2028-08-31
Completion
2028-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject EZOBRESIB Small molecule
Subject Fedratinib Small molecule
Subject Ruxolitinib Small molecule

Indications