Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial
Basic Trial Information
|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||CINC424A2352|
CINCB 18424-352, NCT00934544
This is an open label, randomized study comparing the efficacy and safety of randomized 2:1 INC424/INCB018424 tablets versus best-available therapy, as selected by the investigator. The purpose is to compare the efficacy, safety and tolerability of 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).
Further Study Information
Male or female individuals, aged 18 years or older who have been diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF), were observed to have palpable splenomegaly, were not candidates for stem cell transplantation, and had 2 or more risk factors, thereby placing them in an intermediate-2 or high-risk prognostic group may enroll. Subjects were permitted to have received any or no prior therapy for MF. This is an open label, randomized study comparing the efficacy and safety of INCB018424 tablets versus best-available therapy, as selected by the investigator. The purpose is to compare the efficacy, safety and tolerability of 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).
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors
Novartis Pharmaceuticals Corporation
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00934544
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.