A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination with Ruxolitinib in Participants with Anemia Due to Myeloproliferative Disorders

Clinical Trial Details

The purpose of this study is to evaluate the safety of an investigational drug, “INCB000928” alone and in combination with ruxolitinib (Jakafi), and to find out what effects, if any, the drug or investigational combination has on people with anemia due to myeloproliferative disorders.

This is an open-label study, which means that both you and your study doctor will know whether you are receiving study drug alone or the investigational combination.

“Investigational” means the INCB000928 has not been approved by the US Food and Drug Administration (“FDA”) for use as a prescription or over-the-counter medication.

Ruxolitinib has been approved by the FDA under the trade name JAKAFI® for the treatment of different myeloproliferative neoplasms or blood disorders called myelofibrosis (MF), including primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF), post essential thrombocythemia myelofibrosis (PET-MF) and polycythemia vera.

Key Eligibility:

Participants diagnosed with myelofibrosis who are transfusion-dependent or present with symptomatic anemia, defined as follows:

Anemia: A hemoglobin (Hgb)value less than 10 g/dL demonstrated during screening recorded on 3 separate occasions with at least 7 days between measurements (Note: red blood cell transfusion must have occurred at least 2 weeks before the Hgb measurement was taken).
Transfusion-dependent: Participant has received at least 4 units of red blood cell transfusions during the 28 days or 8 weeks immediately preceding participation in the clinical trial, and the most recent transfusion episode must have occurred within 28 days of beginning the trial.

Confirmed diagnosis of primary myelofibrosis, post-polycythemia vera , or post essential thrombocythemia myelofibrosis
Ineligible to receive or have not responded to other available therapies for anemia, such aserythropoiesis-stimulating agents.
Detailed eligibility criteria will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Ellen K. Ritchie, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2011022963

ClinicalTrials.gov:

NCT04455841

Status

Open to Enrollment

Age Group

Adult

Disease

Myeloproliferative Neoplasms