COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
NCT ID: NCT00952289
Last Updated: 2018-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
309 participants
INTERVENTIONAL
2009-08-31
2015-10-31
Brief Summary
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Detailed Description
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When half of the patients remaining in the study completed the Week 36 visit and all patients enrolled completed Week 24 or discontinued, the database was frozen and the primary analysis was conducted. Once this was complete, all patients were unblinded and patients who had been randomized to placebo were given the opportunity to cross over to ruxolitinib treatment, provided hematology laboratory parameters were adequate; Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ruxolitinib
Participants received ruxolitinib orally twice a day. The starting dose was determined based on Baseline platelet count. Patients with Baseline platelet count \> 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
Ruxolitinib
Ruxolitinib phosphate tablets 5 mg administered as oral doses.
Placebo
Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting certain protocol requirements detailed below were given the opportunity to cross over to ruxolitinib treatment.
Ruxolitinib
Ruxolitinib phosphate tablets 5 mg administered as oral doses.
Placebo
Matching placebo tablets were administered as oral doses in the same manner as active drug.
Interventions
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Ruxolitinib
Ruxolitinib phosphate tablets 5 mg administered as oral doses.
Placebo
Matching placebo tablets were administered as oral doses in the same manner as active drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with myelofibrosis requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
* Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
* Subjects who have not previously received treatment with a Janus kinase (JAK) inhibitor
Exclusion Criteria
* Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
* Subjects with inadequate liver or renal function
* Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
* Subjects with an active malignancy over the previous 5 years except specific skin cancers.
* Subjects with severe cardiac conditions
* Subjects who have had splenic irradiation within 12 months
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: STUDY_DIRECTOR
M.D. Anderson Cancer Center
Locations
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Fullerton, California, United States
Highland, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
Panorama City, California, United States
Rancho Cucamonga, California, United States
Riverside, California, United States
Sacramento, California, United States
San Diego, California, United States
West Covina, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Boynton Beach, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Twin Falls, Idaho, United States
Chicago, Illinois, United States
Beech Grove, Indiana, United States
Indianapolis, Indiana, United States
Ames, Iowa, United States
Iowa City, Iowa, United States
Sioux City, Iowa, United States
Waterloo, Iowa, United States
Louisville, Kentucky, United States
Alexandria, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Novi, Michigan, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Saint Louis Park, Minnesota, United States
New Albany, Mississippi, United States
St Louis, Missouri, United States
Billings, Montana, United States
Denville, New Jersey, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Somerville, New Jersey, United States
Albuquerque, New Mexico, United States
East Setauket, New York, United States
New York, New York, United States
Valhalla, New York, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Akron, Ohio, United States
Canton, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Dover, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
New Braunfels, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Everett, Washington, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Darlinghurst, New South Wales, Australia
Kogarah, New South Wales, Australia
Randwick, New South Wales, Australia
St Leonards, New South Wales, Australia
Brisbane, Queensland, Australia
Douglas, Queensland, Australia
Herston, Queensland, Australia
Milton, Queensland, Australia
Woolloongabba, Queensland, Australia
Bedford Park, South Australia, Australia
Box Hill, Victoria, Australia
Clayton, Victoria, Australia
Frankston, Victoria, Australia
Ringwood East, Victoria, Australia
Fremantle, Western Australia, Australia
Perth, Western Australia, Australia
Vancouver, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Baldwin Park, California, United States
Bellflower, California, United States
Beverly Hills, California, United States
Corona, California, United States
Countries
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References
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Verstovsek S, Mesa R, Gotlib J, et al. Results of COMFORT-I, a randomized double-blind phase III trial of JAK1/2 inhibitor INCB18424 (424) vs placebo (PB) for patients with myelofibrosis (MF). The 47th Annual ASCO meeting, Chicago, IL. J Clin Oncol 2011; 29 (suppl; abstract 6500). Verstovsek S, Mesa R, Gotlib J, et al. Results of COMFORT-I, a randomized, double-blind phase III trial of the JAK1 and JAK2 inhibitor ruxolitinib (INCB018424) versus placebo for patients with myelofibrosis. The 16th Annual EHA meeting, London, UK. Haematologica 2011; 96 (suppl 2; abstract 0505).
Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. doi: 10.1056/NEJMoa1110557.
Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger MW, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner EO, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Sun W, Sandor V, Kantarjian HM. Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013 Dec;98(12):1865-71. doi: 10.3324/haematol.2013.092155. Epub 2013 Sep 13.
Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger MW, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner EO, Lyons RM, Raza A, Vaddi K, Sun W, Peng W, Sandor V, Kantarjian H; COMFORT-I investigators. Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I. Haematologica. 2015 Apr;100(4):479-88. doi: 10.3324/haematol.2014.115840. Epub 2015 Jan 23.
Verstovsek S, Gotlib J, Mesa RA, Vannucchi AM, Kiladjian JJ, Cervantes F, Harrison CN, Paquette R, Sun W, Naim A, Langmuir P, Dong T, Gopalakrishna P, Gupta V. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol. 2017 Sep 29;10(1):156. doi: 10.1186/s13045-017-0527-7.
Miller CB, Komrokji RS, Mesa RA, Sun W, Montgomery M, Verstovsek S. Practical Measures of Clinical Benefit With Ruxolitinib Therapy: An Exploratory Analysis of COMFORT-I. Clin Lymphoma Myeloma Leuk. 2017 Aug;17(8):479-487. doi: 10.1016/j.clml.2017.05.015. Epub 2017 May 12.
Verstovsek S, Mesa RA, Gotlib J, Gupta V, DiPersio JF, Catalano JV, Deininger MW, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner EO, Lyons RM, Paquette R, Raza A, Jones M, Kornacki D, Sun K, Kantarjian H; COMFORT-I investigators. Long-term treatment with ruxolitinib for patients with myelofibrosis: 5-year update from the randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial. J Hematol Oncol. 2017 Feb 22;10(1):55. doi: 10.1186/s13045-017-0417-z.
Deininger M, Radich J, Burn TC, Huber R, Paranagama D, Verstovsek S. The effect of long-term ruxolitinib treatment on JAK2p.V617F allele burden in patients with myelofibrosis. Blood. 2015 Sep 24;126(13):1551-4. doi: 10.1182/blood-2015-03-635235. Epub 2015 Jul 30.
Vannucchi AM, Kantarjian HM, Kiladjian JJ, Gotlib J, Cervantes F, Mesa RA, Sarlis NJ, Peng W, Sandor V, Gopalakrishna P, Hmissi A, Stalbovskaya V, Gupta V, Harrison C, Verstovsek S; COMFORT Investigators. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica. 2015 Sep;100(9):1139-45. doi: 10.3324/haematol.2014.119545. Epub 2015 Jun 11.
Mesa RA, Verstovsek S, Gupta V, Mascarenhas JO, Atallah E, Burn T, Sun W, Sandor V, Gotlib J. Effects of ruxolitinib treatment on metabolic and nutritional parameters in patients with myelofibrosis from COMFORT-I. Clin Lymphoma Myeloma Leuk. 2015 Apr;15(4):214-221.e1. doi: 10.1016/j.clml.2014.12.008. Epub 2014 Dec 27.
Mesa RA, Kiladjian JJ, Verstovsek S, Al-Ali HK, Gotlib J, Gisslinger H, Levy R, Siulnik A, Gupta V, Khan M, DiPersio JF, McQuitty M, Catalano JV, Hunter DS, Knoops L, Deininger M, Cervantes F, Miller C, Vannucchi AM, Silver RT, Barbui T, Talpaz M, Barosi G, Winton EF, Mendeson E, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Sun W, Sandor V, Kantarjian HM, Harrison C. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014 Feb;99(2):292-8. doi: 10.3324/haematol.2013.087650. Epub 2013 Aug 2.
Mesa RA, Gotlib J, Gupta V, Catalano JV, Deininger MW, Shields AL, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH, Hare T, Erickson-Viitanen S, Sun W, Sandor V, Levy RS, Kantarjian HM, Verstovsek S. Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1285-92. doi: 10.1200/JCO.2012.44.4489. Epub 2013 Feb 19.
Other Identifiers
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INCB 18424-351
Identifier Type: -
Identifier Source: org_study_id
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