COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial

Last updated: February 12, 2018
Sponsor: Incyte Corporation
Overall Status: Completed

Phase

3

Condition

Leukemia (Pediatric)

Post-polycythemia Vera Myelofibrosis

Myelofibrosis

Treatment

Placebo

Ruxolitinib

Clinical Study ID

NCT00952289
INCB 18424-351
  • Ages > 18
  • All Genders

Study Summary

This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemiavera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF)according to the 2008 World Health Organization criteria

  • Subjects with myelofibrosis requiring therapy must be classified as high risk ORintermediate risk level 2 according to the prognostic factors defined by theInternational 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

Exclusion Criteria:

  • Subjects with a life expectancy of less than 6 months

  • Subjects with inadequate bone marrow reserve as demonstrated by specific clinicallaboratory counts

  • Subjects with inadequate liver or renal function

  • Subjects with clinically significant bacterial, fungal, parasitic or viral infectionwhich require therapy

  • Subjects with an active malignancy over the previous 5 years except specific skincancers.

  • Subjects with severe cardiac conditions

  • Subjects who have had splenic irradiation within 12 months

Study Design

Total Participants: 309
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 01, 2009
Estimated Completion Date:
October 31, 2015

Study Description

Patients with spleen growth of greater than 25% based on an increase in spleen volume from Baseline were eligible for early unblinding, and for patients on placebo, cross over to ruxolitinib prior to the primary study endpoint being reached. If this spleen growth occurred before Week 24, it must have been accompanied by specific worsening of symptoms, based on worsening early satiety accompanied by weight loss or worsening pain requiring daily narcotic use. After Week 24, asymptomatic spleen growth alone was sufficient for early unblinding and potential cross over. Patients found to have been randomized to ruxolitinib after early unblinding prior to Week 24 were discontinued.

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).

Connect with a study center

  • Darlinghurst, New South Wales
    Australia

    Site Not Available

  • Kogarah, New South Wales
    Australia

    Site Not Available

  • Randwick, New South Wales
    Australia

    Site Not Available

  • St Leonards, New South Wales
    Australia

    Site Not Available

  • Brisbane, Queensland
    Australia

    Site Not Available

  • Douglas, Queensland
    Australia

    Site Not Available

  • Herston, Queensland
    Australia

    Site Not Available

  • Milton, Queensland
    Australia

    Site Not Available

  • Woolloongabba, Queensland
    Australia

    Site Not Available

  • Bedford Park, South Australia
    Australia

    Site Not Available

  • Box Hill, Victoria
    Australia

    Site Not Available

  • Clayton, Victoria
    Australia

    Site Not Available

  • Frankston, Victoria
    Australia

    Site Not Available

  • Ringwood East, Victoria
    Australia

    Site Not Available

  • Fremantle, Western Australia
    Australia

    Site Not Available

  • Perth, Western Australia
    Australia

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • Halifax, Nova Scotia
    Canada

    Site Not Available

  • London, Ontario
    Canada

    Site Not Available

  • Ottawa, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Levis, Quebec
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Scottsdale, Arizona
    United States

    Site Not Available

  • Baldwin Park, California
    United States

    Site Not Available

  • Bellflower, California
    United States

    Site Not Available

  • Beverly Hills, California
    United States

    Site Not Available

  • Corona, California
    United States

    Site Not Available

  • Fullerton, California
    United States

    Site Not Available

  • Highland, California
    United States

    Site Not Available

  • La Jolla, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Orange, California
    United States

    Site Not Available

  • Palo Alto, California
    United States

    Site Not Available

  • Panorama City, California
    United States

    Site Not Available

  • Rancho Cucamonga, California
    United States

    Site Not Available

  • Riverside, California
    United States

    Site Not Available

  • Sacramento, California
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • West Covina, California
    United States

    Site Not Available

  • Aurora, Colorado
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Fort Collins, Colorado
    United States

    Site Not Available

  • Norwalk, Connecticut
    United States

    Site Not Available

  • Washington, District of Columbia
    United States

    Site Not Available

  • Boynton Beach, Florida
    United States

    Site Not Available

  • Gainesville, Florida
    United States

    Site Not Available

  • Jacksonville, Florida
    United States

    Site Not Available

  • West Palm Beach, Florida
    United States

    Site Not Available

  • Winter Park, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Augusta, Georgia
    United States

    Site Not Available

  • Honolulu, Hawaii
    United States

    Site Not Available

  • Boise, Idaho
    United States

    Site Not Available

  • Meridian, Idaho
    United States

    Site Not Available

  • Twin Falls, Idaho
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Beech Grove, Indiana
    United States

    Site Not Available

  • Indianapolis, Indiana
    United States

    Site Not Available

  • Ames, Iowa
    United States

    Site Not Available

  • Iowa City, Iowa
    United States

    Site Not Available

  • Sioux City, Iowa
    United States

    Site Not Available

  • Waterloo, Iowa
    United States

    Site Not Available

  • Louisville, Kentucky
    United States

    Site Not Available

  • Alexandria, Louisiana
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • Ann Arbor, Michigan
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • Novi, Michigan
    United States

    Site Not Available

  • Southfield, Michigan
    United States

    Site Not Available

  • Minneapolis, Minnesota
    United States

    Site Not Available

  • Rochester, Minnesota
    United States

    Site Not Available

  • Saint Louis Park, Minnesota
    United States

    Site Not Available

  • empty

    St. Louis Park, Minnesota
    United States

    Site Not Available

  • New Albany, Mississippi
    United States

    Site Not Available

  • Saint Louis, Missouri
    United States

    Site Not Available

  • empty

    St. Louis, Missouri
    United States

    Site Not Available

  • Billings, Montana
    United States

    Site Not Available

  • Denville, New Jersey
    United States

    Site Not Available

  • Hackensack, New Jersey
    United States

    Site Not Available

  • Morristown, New Jersey
    United States

    Site Not Available

  • Somerville, New Jersey
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • East Setauket, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Valhalla, New York
    United States

    Site Not Available

  • Durham, North Carolina
    United States

    Site Not Available

  • Hickory, North Carolina
    United States

    Site Not Available

  • Winston-Salem, North Carolina
    United States

    Site Not Available

  • Bismarck, North Dakota
    United States

    Site Not Available

  • Akron, Ohio
    United States

    Site Not Available

  • Canton, Ohio
    United States

    Site Not Available

  • Cleveland, Ohio
    United States

    Site Not Available

  • Dayton, Ohio
    United States

    Site Not Available

  • Dover, Ohio
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Charleston, South Carolina
    United States

    Site Not Available

  • Germantown, Tennessee
    United States

    Site Not Available

  • Memphis, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • New Braunfels, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • Burlington, Vermont
    United States

    Site Not Available

  • Everett, Washington
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.