An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis
NCT ID: NCT01633372
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2012-07-16
2021-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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itacitinib 100 mg
itacitinib 100 mg twice a day
itacitinib
itacitinib 200 mg
itacitinib 200 mg twice a day
itacitinib
itacitinib 300 mg
itacitinib 300 mg once a day
itacitinib
itacitinib 400 mg
itacitinib 400 mg once a day
itacitinib
itacitinib 600 mg
itacitinib 600 mg once a day
itacitinib
Interventions
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itacitinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Assad, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Countries
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References
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Mascarenhas JO, Talpaz M, Gupta V, Foltz LM, Savona MR, Paquette R, Turner AR, Coughlin P, Winton E, Burn TC, O'Neill P, Clark J, Hunter D, Assad A, Hoffman R, Verstovsek S. Primary analysis of a phase II open-label trial of INCB039110, a selective JAK1 inhibitor, in patients with myelofibrosis. Haematologica. 2017 Feb;102(2):327-335. doi: 10.3324/haematol.2016.151126. Epub 2016 Oct 27.
Other Identifiers
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INCB 39110-230
Identifier Type: -
Identifier Source: org_study_id
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