Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
NCT ID: NCT00509899
Last Updated: 2018-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
154 participants
INTERVENTIONAL
2007-06-30
2017-02-28
Brief Summary
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Detailed Description
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Part 1: Dose escalation and determination of maximum tolerated dose (complete).
Part 2: Exploration of alternative dosing schedules (complete).
Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival (ongoing).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ruxolitinib
All participants received oral ruxolitinib. Patients began treatment with either 10 mg twice a day (bid), 15 mg bid, 25 mg bid, 50 mg bid, 25 mg once a day (qd), 50 mg qd, 100 mg qd, or 200 mg qd, depending on the time period when they entered the study. The doses were titrated based on efficacy and safety to a maximum of 25 mg bid for patients who entered the study after sufficient dosing information had been obtained to define the maximum dose for patients in the study. Patients could continue receiving treatment indefinitely if receiving benefit at a dose that continues to maintain benefit but does not exceed a maximum dose of 25 mg BID.
Ruxolitinib
5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.
Interventions
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Ruxolitinib
5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with myelofibrosis requiring therapy
* Adequate bone marrow reserve
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Srdan Verstovsek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center, Houston, TX
Ayalew Tefferi, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Rochester, MN
Locations
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Rochester, Minnesota, United States
Houston, Texas, United States
Countries
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References
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Verstovsek S, Kantarjian H, Mesa RA, Pardanani AD, Cortes-Franco J, Thomas DA, Estrov Z, Fridman JS, Bradley EC, Erickson-Viitanen S, Vaddi K, Levy R, Tefferi A. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010 Sep 16;363(12):1117-27. doi: 10.1056/NEJMoa1002028.
Verstovsek S, Kantarjian HM, Estrov Z, Cortes JE, Thomas DA, Kadia T, Pierce S, Jabbour E, Borthakur G, Rumi E, Pungolino E, Morra E, Caramazza D, Cazzola M, Passamonti F. Long-term outcomes of 107 patients with myelofibrosis receiving JAK1/JAK2 inhibitor ruxolitinib: survival advantage in comparison to matched historical controls. Blood. 2012 Aug 9;120(6):1202-9. doi: 10.1182/blood-2012-02-414631. Epub 2012 Jun 20.
Kvasnicka HM, Thiele J, Bueso-Ramos CE, Sun W, Cortes J, Kantarjian HM, Verstovsek S. Long-term effects of ruxolitinib versus best available therapy on bone marrow fibrosis in patients with myelofibrosis. J Hematol Oncol. 2018 Mar 15;11(1):42. doi: 10.1186/s13045-018-0585-5.
Other Identifiers
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INCB 18424-251
Identifier Type: -
Identifier Source: org_study_id
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