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

Sponsor:	Incyte Corporation
Information provided by:	Incyte Corporation
ClinicalTrials.gov Identifier:	NCT00952289

Purpose

This is a randomized, double-blind study comparing the efficacy and safety of 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). Male or female individuals, aged 18 years or older 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 be enrolled. Individuals may be either JAK2 V617F-negative or JAK2 V617F-positive and be eligible for participation.

Condition	Intervention	Phase
Myelofibrosis	Drug: INCB018424 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to 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 Incyte Corporation:

Primary Outcome Measures:

Proportion of subjects achieving ≥ 35% reduction in spleen volume from Baseline to Week 24 as assessed by MRI or CT [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of maintenance of a ≥ 35% reduction from Baseline in spleen volume among subjects initially randomized to receive INCB018424 [ Time Frame: Baseline Visit, Week 12 Visit and every 12 weeks until the 'End of Study' Visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	August 2009
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
INCB018424: Experimental Starting doses of 15 mg BID (3 x 5 mg tablets) or 20 mg BID (4 x 5 mg tablets); Dose titration ranges from 5 mg BID to 25 mg BID during study conduct	Drug: INCB018424 Tablet; Starting doses of ether 15 mg BID or 20 mg BID; Dose titration ranges from 5 mg BID to 25 mg BID during study conduct; Daily administration
Placebo: Placebo Comparator Placebo tablet matching INCB018424 tablet	Drug: Placebo Tablet; Starting dose of 15 mg BID or 20 mg BID; Dose titration from 5 mg BID to 25 mg BID during study conduct; Daily administration

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 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 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: NCT00952289

Show 112 Study Locations

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director:

Srdan Verstovsek, MD, PhD

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	Incyte Corporation ( Pam Murphy, Investor Relations and Corporate Management )
ClinicalTrials.gov Identifier:	NCT00952289 History of Changes
Other Study ID Numbers:	INCB 18424-351
Study First Received:	August 4, 2009
Last Updated:	June 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Incyte Corporation:

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 September 07, 2010