A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Incyte Corporation

Summary

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Life expectancy \> 6 months. * Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease). * Participants with MF, PV and ET as defined in the protocol. Exclusion Criteria: * Presence of any hematological malignancy other than MF, PV, or ET. * Malignancy within the last 3 years prior to enrollment. * Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection. * Clinically significant or uncontrolled cardiac disease. * Has undergone any prior allogeneic stem-cell transplantation or such transplantation i…

Interventions

Drug
INCA036978
INCA036978 will be administered at protocol defined dose.
Drug
Standard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Locations (47)

University of Alabama At Birmingham
Birmingham, Alabama
City of Hope-Lennar Foundation Cancer Center
Irvine, California
Usc Norris Comprehensive Cancer Center
Los Angeles, California
UCLA Medical Hematology & Oncology
Los Angeles, California
Yale Cancer Center
New Haven, Connecticut
University of Miami
Miami, Florida