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About
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 (MF) and other myeloid neoplasms.
Enrollment
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Inclusion criteria
Age 18 years and older at the time of signing the informed consent.
Part 1 Monotherapy: Participants with confirmed diagnosis of relapsed or refractory MF (primary, or post-PV and post-ET), MDS, MDS/MPN, or ET who have received at least 1 prior line of therapy; are either refractory, relapsed, or intolerant to the last therapy; and there is no available therapy that would provide clinical benefit in the opinion of the investigator.
Part 2 Combination with ruxolitinib.
Must not be a candidate for potentially curative therapy, including hematopoietic stem cell transplantation.
ECOG performance status 0 to 2.
Life expectancy ≥ 24 weeks.
Willingness to avoid pregnancy or fathering children based on criteria.
Exclusion criteria
Prior receipt of a BET inhibitor.
Receipt of anticancer medications or investigational drugs within the protocol-defined interval before the first dose of study treatment. For Part 2 JAKi-naive, prior use of a JAK inhibitor (including ruxolitinib) and no use of experimental drug therapy for MF or any other standard drug (except hydroxyurea) used for MF or another indication within 3 months of starting study drug. Hydroxyurea must be discontinued 3 weeks prior to starting study treatment. For participants with suboptimal response to ruxolitinib, ruxolitinib will continue at the participants' current ongoing doses, no ruxolitinib washout is needed.
Participants with exclusionary laboratory values at screening defined as, including, but not limited to,
inadequate renal, hepatic and coagulation functions as defined in the protocol.
Concurrent anticancer therapy other than the therapies being tested in this study.
Participants who have received allogeneic hematopoietic stem cell transplantation within 6 months of enrollment (unless approved by the medical monitor), or have active graft versus-host disease, or have received immunosuppressive therapy following allogeneic transplant within 2 weeks of the first dose of study treatment.
Unless approved by the medical monitor, may not have received autologous hematopoietic stem-cell transplant within 3 months before the first dose of study treatment.
Significant concurrent, uncontrolled medical condition, including but not limited to, significant GI disorder, history of or current clinically significant or uncontrolled cardiac disease, history or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful, and history of bleeding disorder or at a high risk of bleeding.
Active bacterial, fungal, parasitic, or viral infection that requires therapy.
Current use of prohibited medication as described in the protocol, including the use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study treatment.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
216 participants in 2 patient groups
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Central trial contact
Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)
Data sourced from clinicaltrials.gov
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