Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

  • STATUS
    Recruiting
  • End date
    Nov 11, 2024
  • participants needed
    39
  • sponsor
    Incyte Corporation
Updated on 19 November 2021
myelofibrosis
cell transplantation

Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis and other myeloid neoplasms.

Details
Condition Bone marrow disorder, Preleukemia, Myelosclerosis with myeloid metaplasia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Secondary Myelofibrosis, Myeloproliferative Neoplasms, Myelofibrosis, Relapsed or Refractory Primary Myelofibrosis, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, myelodysplastic syndrome (mds), Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome, Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome, Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome
Treatment Ruxolitinib, INCB057643
Clinical Study IdentifierNCT04279847
SponsorIncyte Corporation
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Relapsed or refractory primary myelofibrosis (MF), secondary MFs (post-polycythemia vera MF, post- essential thrombocythemia MF) myeloproliferative neoplasm (MPN), myelodysplastic syndrome (MDS), and myelodysplastic/myeloproliferative neoplasm overlap syndrome (MDS/MPN)
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 a BET inhibitor within 5 half-lives of the compound, and/or experienced BET inhibitor-related AE(s) resulting in dose discontinuation
Receipt of anticancer medications or investigational drugs within the protocol-defined interval before the first dose of study treatment
Note: For participants in Part 2, Treatment Group B, ruxolitinib will continue
at the participants' current, ongoing doses. No ruxolitinib washout is needed
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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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