A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis

  • STATUS
    Recruiting
Updated on 29 September 2020

Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy for participants with relapsed or refractory myelofibrosis.

Details
Condition Blood Cancer
Clinical Study IdentifierTX253571
Last Modified on29 September 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Relapsed or refractory primary myelofibrosis (MF) or secondary MFs (post-polycythemia vera MF, post-essential thrombocythemia MF)
Must not be a candidate for potentially curative therapy, including hematopoietic stem-cell transplantation
Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate at screening/baseline, or archival sample obtained since completion of most recent therapy
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Prior receipt of any BET inhibitor
Have received allogeneic hematopoietic stem-cell transplant within 6 months of enrollment or have active graft-versus-host disease, or have received immunosuppressive therapy following allogeneic transplant within 2 weeks of Cycle 1 Day 1
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug
History of bleeding disorder or at a high risk of bleeding (eg, chronic liver disease, prior gastrointestinal bleed)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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