About this trial
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.
PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
Disqualifiers
Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.
Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.
Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.
Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
Trial design
Treatments tested in this trial
- INCB160058
- Standard disease-directed therapy