Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial

• Status: Completed
• Trial end date: 2015-03-04
• Target enrollment: 0
• Participant gender: All

Summary

This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Subjects must be diagnosed with PMF, PPV-MF or PET-MF according to the 2008 World Health Organization criteria

• Subjects with MF 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 ECOG performance status of 0, 1, 2 or 3

• Subjects with peripheral blood blast count of < 10%.

• Subjects who have not previously received treatment with a 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 any history of platelet counts < 50,000/µL or ANC < 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason

• 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