Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Purpose

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.

Condition

  • Myeloproliferative Neoplasms

Eligibility

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

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 is planned in the next 6 months. - Laboratory values outside the Protocol-defined ranges. - Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment. - Presence of chronic or current active infectious disease requiring systemic treatment. - Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug. - Prior radiation therapy within 28 days before the first dose of study treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1a: Dose Escalation 		INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s).
  • Drug: INCA036978
    INCA036978 will be administered at protocol defined dose.
Experimental
Part 1b: Dose Escalation 		INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s).
  • 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.
Experimental
Part 2a: Dose Expansion 		INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1
  • Drug: INCA036978
    INCA036978 will be administered at protocol defined dose.
Experimental
Part 2b: Dose Expansion 		INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1.
  • 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.

Recruiting Locations

Winship Cancer Institute of Emory University
Atlanta, Georgia 30322

Ohio State University
Columbus, Ohio 43210

Tristar Bmt/Tcto
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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