An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis

Completed · Phase 2

Conditions studied: MPN (Myeloproliferative Neoplasms)

In brief

This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).

Key facts

Study ID

NCT01633372

Run by

Incyte Corporation

People needed

87

Starts

2012-07-16

Expected to finish

2021-06-29

Last updated by the study team

2021-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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