A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

Purpose

This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.

Condition

  • Myeloproliferative Neoplasms

Eligibility

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

Inclusion Criteria

  • Life expectancy > 6 months. - Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease). - Existing documentation from a qualified local laboratory of CALR exon-9 mutation. - Participants with MF or ET as defined in the protocol.

Exclusion Criteria

  • Presence of any hematological malignancy other than ET, PMF, or post-ET MF. - Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. - Participants with laboratory values exceeding the protocol defined thresholds. - Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. - Active invasive malignancy over the previous 2 years. - History of clinically significant or uncontrolled cardiac disease. - Active HBV/HCV or known history of HIV. - Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. - Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists 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 1a Dose Escalation Cohort Disease Group A - with MF 		INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles 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: INCA033989
    INCA033989 will be administered at protocol defined dose.
Experimental
Part 1a Dose Escalation Cohort Disease Group A - with ET 		INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with essential thrombocythemia (ET) will enroll in this group.
  • Drug: INCA033989
    INCA033989 will be administered at protocol defined dose.
Experimental
Part 1b: Dose Expansion - with MF 		INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.
  • Drug: INCA033989
    INCA033989 will be administered at protocol defined dose.
Experimental
Part 1b: Dose Expansion - with ET 		INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.
  • Drug: INCA033989
    INCA033989 will be administered at protocol defined dose.

Recruiting Locations

The University of Kansas Cancer Center
Westwood, Kansas 66205

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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