Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms (LIMBER)
Myelofibrosis, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome
About this trial
This is an interventional treatment trial for Myelofibrosis focused on measuring Myelofibrosis, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm overlap syndrome, myeloproliferative neoplasm, BET protein inhibitor, relapsed primary myelofibrosis, refractory primary myelofibrosis, secondary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis, LIMBER
Eligibility Criteria
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.
Sites / Locations
- University of Alabama At BirminghamRecruiting
- University of Colorado Cancer CenterRecruiting
- University of Miami Sylvester Comprehensive Cancer CenterRecruiting
- Emory University-Winship Cancer InstituteRecruiting
- University of North Carolina At Chapel HillRecruiting
- University of Cincinnati Cancer Institute
- Md Anderson Cancer CenterRecruiting
- Huntsman Cancer Institute At University of UtahRecruiting
- Seattle Cancer Care AllianceRecruiting
- St Paul'S HospitalRecruiting
- Princess Margaret Cancer CenterRecruiting
- Helsinki University Central HospitalRecruiting
- L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - MalpighiRecruiting
- Azienda Ospedaliero-Universitaria Careggi (Aouc)Recruiting
- Fondazione Irccs Ca Granda Ospedale MaggioreRecruiting
- Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
- Azienda Ospedaliera Universitaria Integrata Di Verona - Centro Ricerche Cliniche Dr Verona
- Fujita Health University Hospital
- Chiba University HospitalRecruiting
- National Cancer Center Hospital EastRecruiting
- University of Yamanashi HospitalRecruiting
- Kyushu University Hospital
- Ico Hospital Germans Trias I PujolRecruiting
- Hospital Universitario Insular de Gran CanariaRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario Virgen de La ArrixacaRecruiting
- Hospital Clinico Universitario de SalamancaRecruiting
- United Lincolnshire Hospitals
- The Christie Nhs Foundation Trust UkRecruiting
- University of OxfordRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1 : INCB057643 Monotherapy
Part 2 : INCB057643 Combination with Ruxolitinib
INCB057643 dose escalation and dose expansion
Combination arm in dose escalation and dose expansion