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

Purpose

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

Condition

  • Myeloproliferative Neoplasms

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years - Participants with intermediate-1 or higher risk PMF, post-PV, of post-ET MF, histologically confirmed - Evidence of minimum burden of disease based on symptoms and/or splenomegaly - Life expectancy > 6 months - Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease) - Existing documentation of JAK2V617F mutation from a qualified local laboratory - Previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment

Exclusion Criteria

  • Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, or post-ET MF - 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 - Active invasive malignancy - Significant concurrent, uncontrolled medical condition - Active HBV/HCV or known HIV - Any prior MF-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment - Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Dose Escalation - with MF 		INCB160058 will be administered at a protocol defined starting regimen to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) will enroll in this group.
  • Drug: INCB160058
    Oral; Tablet
Experimental
Part 2 Dose Expansion - with MF 		INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF will enroll in this group.
  • Drug: INCB160058
    Oral; Tablet

Recruiting Locations

The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
Fairway, Kansas 66205

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com