Study of INCA036978 for Myeloproliferative Neoplasms
This study is testing a new drug called INCA036978, both on its own and combined with standard treatments, for people with Myeloproliferative Neoplasms (MPN). MPN are a group of blood cancers that start in the bone marrow. The main goals are to find out how safe INCA036978 is, what side effects it might cause, and to determine the best dose. We are looking for 218 participants aged 18 and older who have Myelofibrosis (MF), Polycythemia Vera (PV), or Essential Thrombocythemia (ET). The study will track side effects for up to approximately 2 years. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 218 participants. The phase of the study is not specified.
- What's involved
- You would need to be willing to have bone marrow biopsies before and during the study. The study will track side effects for up to approximately 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for treatment-emergent adverse events for up to approximately 2 years.
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Study of INCA036978 in Participants With Myeloproliferative Neoplasms
At a glance
Conditions
Where it's being run
54 sites across 29 statesStudy leadership
- Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of participants with Dose Limiting Toxicities (DLT)s in Part 1Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
- Number of participants with Treatment-emergent Adverse Events (TEAEs)Up to approximately 2 years
Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
- Number of participants with TEAEs leading to dose modification or discontinuationUp to approximately 2 years
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.