RecruitingMyeloproliferative Neoplasms

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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 as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.

Sponsor: Incyte Corporation

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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 or chronic HBV or active 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, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.