Myeloproliferative Neoplasms Clinical Trial
An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis
Summary
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
Eligibility Criteria
Inclusion Criteria:
Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
Must score at least 1 point on the Dynamic International Prognostic Scoring System (DIPSS) for prognostic risk factors and have peripheral blast count <10% at both Screening and Baseline hematology assessments.
Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14.
Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC) >/= 1x10^9/L.
Subjects must have palpable spleen or history of splenectomy
Active symptoms at the screening visit
Exclusion 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.
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There is 1 Location for this study
Birmingham Alabama, , United States
Scottsdale Arizona, , United States
Los Angeles California, , United States
Atlanta Georgia, , United States
Baltimore Maryland, , United States
Ann Arbor Michigan, , United States
New York New York, , United States
Portland Oregon, , United States
Philadelphia Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
Columbia South Carolina, , United States
Memphis Tennessee, , United States
Nashville Tennessee, , United States
Houston Texas, , United States
Darlinghurst New South Wales, , Australia
Kogarah New South Wales, , Australia
Box Hill Victoria, , Australia
Frankston Victoria, , Australia
Edmonton Alberta, , Canada
Vancouver British Columbia, , Canada
Toronto Ontario, , Canada
Montreal Quebec, , Canada
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