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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00934544

Purpose

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) who are either resistant or refractory to, intolerant of, or in the investigator's opinion not candidates for available therapy and for whom treatment of MF is indicated may enroll. 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).

Condition	Intervention	Phase
Myelofibrosis	Other: Best-available oral and/or parenteral therapies Drug: INCB018424	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Study of INCB018424 Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia polycythemia vera

MedlinePlus related topics: Spleen Diseases

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Proportion of subjects achieving at least 35% reduction in spleen volume. [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of maintenance of a ≥ 35% reduction from Baseline in spleen volume. [ Time Frame: Baseline and every 12 weeks up to Week 72. After Week 72, every 24 weeks this outcome will be evaluated. ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	July 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
INCB018424: Experimental Starting dose of 15 mg BID or 20 mg BID; Dose titration ranging from 5 mg BID to 25 mg BID is permitted during study conduct	Drug: INCB018424 Tablet; Starting dose either 15 mg BID or 20 mg BID; Dose titration ranging from 5 mg BID to 25 mg BID is permitted during the conduct of the study
Best available therapy Best-available therapy may include a combination of available agents to treat the disease and/or its symptoms, or no therapy, and will be selected by the investigator for each subject. Therapy may be changed at any time during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) may be used.	Other: Best-available oral and/or parenteral therapies Best-available therapy will be administered according to manufacturer's instructions and investigator discretion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934544

Show 62 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
ClinicalTrials.gov Identifier:	NCT00934544 History of Changes
Other Study ID Numbers:	CINCB 18424-352
Study First Received:	July 6, 2009
Last Updated:	August 20, 2010
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:

Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Post-Essential Thrombocythemia Myelofibrosis

Additional relevant MeSH terms:

Myelofibrosis
Myeloid Metaplasia
Polycythemia
Polycythemia Vera
Thrombocythemia, Hemorrhagic
Thrombocytosis
Myeloproliferative Disorders

Bone Marrow Diseases
Hematologic Diseases
Splenic Diseases
Lymphatic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 31, 2010