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Closed (no longer recruiting)Last updated: 4 March 2024

This phase I trial aims to understand how safe, well tolerated and effective a new targeted cancer drug (BMS-986158) is in people with DIPSS-intermediate or high risk Myelofibrosis, when given alone or in combination with targeted cancer treatment (Ruxolitinib or Fedratinib)A Phase 1b Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

Clinical summary

Summary

This trial contains two parts. Part 1 will compare the combination of BMS-986158 with either Ruxolitinib or Fedratinib and Part 2 will compared these combinations with BMS-986158 alone.

Conditions

This trial is treating patients with Dynamic International Prognostic Scoring System (DIPSS)-Intermediate or High Risk Myelofibrosis.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 1b Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

Eligibility

Inclusion

  • 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

  • Women who are pregnant or breastfeeding at screening
  • Any significant acute or uncontrolled chronic medical illness

Other protocol-defined inclusion/exclusion criteria apply

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.