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).

View Eligibility Criteria

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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

87

Study ID:

NCT01633372

Recruitment Status:

Completed

Sponsor:

Incyte Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Birmingham Hematology Oncology Associates, LLC
Birmingham Alabama, , United States
Mayo Clinic, Arizona
Scottsdale Arizona, , United States
UCLA Hematology & Oncology
Los Angeles California, , United States
Emory University
Atlanta Georgia, , United States
St Agnes Hospital
Baltimore Maryland, , United States
University of Michigan Cancer Center
Ann Arbor Michigan, , United States
Mount Sinai School of Medicine
New York New York, , United States
Oregon Health & Science University
Portland Oregon, , United States
University of Pennsylvania Health System
Philadelphia Pennsylvania, , United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania, , United States
South Carolina Oncology & Associates
Columbia South Carolina, , United States
Boston Baskin Cancer Foundation, Inc.
Memphis Tennessee, , United States
Tennessee Oncology
Nashville Tennessee, , United States
MD Anderson Cancer Center
Houston Texas, , United States
St Vincent's Hospital
Darlinghurst New South Wales, , Australia
St. George Hospital
Kogarah New South Wales, , Australia
Box Hill Hospital
Box Hill Victoria, , Australia
Frankston Hospital
Frankston Victoria, , Australia
Cross Cancer Institute
Edmonton Alberta, , Canada
St. Paul's Hospital
Vancouver British Columbia, , Canada
Princess Margaret Hospital
Toronto Ontario, , Canada
St. Mary's Hospital
Montreal Quebec, , Canada

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

87

Study ID:

NCT01633372

Recruitment Status:

Completed

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider