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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.