IRB #

IRB00008830

Title

An Open-Label, Multiple Simon 2-Stage Study of INCB039110 Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera-Myelofibrosis (PPVMF) or Post Essential Thrombocythemia-Myelofibrosis (PET-MF)

Principal Investigator

Angela Fleischman

Study Purpose

The purpose of this study is to evaluate a new drug called INCB 39110 designed to treat symptoms caused by myelofibrosis. We want to see if the drug is safe and effective.
Myelofibrosis is a disorder of the bone marrow in which the marrow is replaced by scar (fibrous) tissue. Scarring of the bone marrow means the marrow is not able to make enough blood cells. As a result, the liver and spleen try to make some of these blood cells. This causes these organs to swell.
The study drug will be tested at different dose levels in two groups of subjects (1 & 2) diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF), or post essential thrombocythemia-myelofibrosis (PET-MF).

Medical Condition(s)

primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF), or post essential thrombocythemia-myelofibrosis (PET-MF).

Eligibility Criteria

Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.

Subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy.

Subjects with unstable cardiac function or invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.

Subjects who have received prior JAK inhibitors may be enrolled with Sponsor approval.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

33 weeks

Minors Included

No

Contact

Nan Subbiah
503-494-4603
subbiahn@ohsu.edu

Sponsor

Incyte Corporation

Recruitment End

01/01/2015

Compensation Provided

No