Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)
NCT ID: NCT01348490
Last Updated: 2020-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2011-06-15
2018-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ruxolitinib 5 mg
Participants began administration with 5 mg ruxolitinib twice daily (BID) orally. Beginning at the Week 4 visit, doses of ruxolitinib could be increased in 5 mg once a day (QD) increments every 4 weeks every 4 weeks not to exceed a dose of 25 mg BID.
Ruxolitinib
Ruxolitinib (INCB018424), 5 mg bid
Interventions
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Ruxolitinib
Ruxolitinib (INCB018424), 5 mg bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
* INR \<= 1.5 or PTT value \< 1.5 x upper limit of normal (ULN) at study entry
* Hemoglobin level at least 6.5 g/dL at Screening visit
* Willingness to be transfused to treat low hemoglobin levels
Exclusion Criteria
* Males who cannot comply with birth control use to avoid fathering a child
* Platelet count \< 50 x10\^9/L or absolute neutrophil count (ANC) \< 1 x10\^9/L at the Screening visit
* Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be \> 1.5 x upper limit of normal at study entry.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Langmuir, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Birmingham, Alabama, United States
Beverly Hills, California, United States
Burbank, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Pomona, California, United States
San Diego, California, United States
New Haven, Connecticut, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Orange City, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Southfield, Michigan, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Somerville, New Jersey, United States
New York, New York, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Canton, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Danville, Pennsylvania, United States
Hershey, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Countries
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References
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Talpaz M, Prchal J, Afrin L, Arcasoy M, Hamburg S, Clark J, Kornacki D, Colucci P, Verstovsek S. Safety and Efficacy of Ruxolitinib in Patients with Myelofibrosis and Low Platelet Counts (50 - 100 x 109/L): Final Analysis of an Open-Label Phase 2 Study. Clin Lymphoma Myeloma Leuk. 2022 May;22(5):336-346. doi: 10.1016/j.clml.2021.10.016. Epub 2021 Nov 2.
Talpaz M, Paquette R, Afrin L, Hamburg SI, Prchal JT, Jamieson K, Terebelo HR, Ortega GL, Lyons RM, Tiu RV, Winton EF, Natrajan K, Odenike O, Claxton D, Peng W, O'Neill P, Erickson-Viitanen S, Leopold L, Sandor V, Levy RS, Kantarjian HM, Verstovsek S. Interim analysis of safety and efficacy of ruxolitinib in patients with myelofibrosis and low platelet counts. J Hematol Oncol. 2013 Oct 29;6(1):81. doi: 10.1186/1756-8722-6-81.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB18424-258
Identifier Type: -
Identifier Source: org_study_id
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