OHSU

IRB #

IRB00010272

Title

A Randomized, Open-Label, 2-Stage Study of INCB047986 Administered Orally to Subjects With Primary Myelodysplastic Syndrome (MDS) Refractory to or Unlikely to respond to ESAs.

Principal Investigator

Kim-Hien Dao

Study Purpose

The specific purpose of this study is to test the effects, good and bad, of INCB047986 (referred to as the study drug) in people with Myelodysplastic Syndrome (MDS) at different dose levels. Another purpose of the study is to test the effects, good and bad, of the study drug in combination with Erythropoiesis-stimulating agents (ESAs).

Medical Condition(s)

Myelodysplastic Syndrome (MDS) Refractory to or Unlikely to Respond to Erythropoiesis-Stimulating Agents (ESAs)

Eligibility Criteria

18+ years of age
MDS diagnosis according to WHO classification for de novo or primary MDS
no prior hypomethylating agents or immunosuppressive therapy for MDS

Age Range

18 - 110

Healthy Volunteers Needed

No

Duration of Participation

At least 16 weeks - indefinite as long as participants are receiving benefit from study treatment

Minors Included

No

Contact

Nan Subbiah 503-494-4603
or
Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Incyte Corporation

Recruitment End

12/05/2019

Compensation Provided

No


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