A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

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

Treatment groups

186 Participants
are divided into 4 treatment groups

Sponsors and collaborators