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

Completed · Phase 3 · Has a placebo group

Conditions studied: MPN (Myeloproliferative Neoplasms)

In brief

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).

Key facts

Study ID

NCT00952289

Run by

Incyte Corporation

People needed

309

Starts

2009-08-01

Expected to finish

2015-10-01

Last updated by the study team

2018-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-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 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

You may not qualify if…

• Subjects with a life expectancy of less than 6 months
• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Baldwin Park, California, United States
• Study site — Bellflower, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Corona, California, United States
• Study site — Fullerton, California, United States
• Study site — Highland, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Palo Alto, California, United States
• Study site — Panorama City, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — Riverside, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — West Covina, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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