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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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