Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
NCT ID: NCT00764309
Last Updated: 2012-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
47 participants
INTERVENTIONAL
2009-01-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A1
dasatinib
Tablets, Oral, 100 mg, once daily, 6 months
Interventions
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dasatinib
Tablets, Oral, 100 mg, once daily, 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* meet American College of Rheumatology (ACR) criteria for scleroderma
* have clinical evidence of active skin disease with a skin score of ≥15
* have had the onset of their first non-Raynaud phenomenon feature of SSc no more than 3 years prior to screening
* have evidence of fibrosing alveolitis (active pulmonary fibrosis) manifested by a forced vital capacity (FVC) between 45% and 80% of predicted normal and/or diffusing capacity (DLCO) between 30% and 70% of predicted normal values
* have an abnormal high resolution Computed tomography (CT) scan of the chest/lungs demonstrating typical ground glass changes of alveolitis with background fibrosis
* have adequate renal function- no evidence of renal crisis in the 2 months prior to enrollment and serum creatinine \< 3 mg/dL
* for both sexes, must use an acceptable form of birth control
* age ≥ 18
Exclusion Criteria
* Clinically significant cardiac disease (New York Heart Association Class III or IV) including preexisting arrhythmia, (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"), myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, cardiomyopathy, or pericardial disease
* Clinically-significant coagulation or platelet function disorder (eg, known von Willebrand's disease)
* Abnormal QTcF interval prolonged (\> 450 msec) after electrolytes have been corrected on baseline electrocardiogram
Laboratory Test Findings
* Hgb \< 10 g/dL; platelet count \< 100,000/dL; WBC \< 3,000/dL; PMN \< 1,000/dL; OR lymphocytes \< 350/dL
* The presence of any of the following laboratory findings at screening: positive for antibodies to hepatitis C virus; positive for antibodies to hepatitis B surface antigen (HBsAg); serum bilirubin 2 times normal, Alanine Aminotransferase (ALT), or Aspartate Aminotransferase (AST)\> 2.5 times upper limit of normal
Prohibited Treatments and/or Therapies
* use of other immunosuppressive therapies must be discontinued at enrollment, eg methotrexate, azathioprine, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, cyclosporine
* treatment with any other experimental or investigational drug(s) concurrently or less than 12 weeks prior to study enrollment
* use of anti-fibrotic agents must be discontinued at enrollment, eg colchicine, D-penicillamine, minocycline or Type 1 oral collagen
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Ucla Division Of Rheumatology
Los Angeles, California, United States
University Of Connecticut Health Center
Farmington, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
Boston University School Of Medicine
Boston, Massachusetts, United States
University Of Michigan
Ann Arbor, Michigan, United States
West Michigan Rheumatology
Grand Rapids, Michigan, United States
Umdnj Clinical Research Center
New Brunswick, New Jersey, United States
Hospital For Special Surgery
New York, New York, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Martyanov V, Kim GJ, Hayes W, Du S, Ganguly BJ, Sy O, Lee SK, Bogatkevich GS, Schieven GL, Schiopu E, Marangoni RG, Goldin J, Whitfield ML, Varga J. Novel lung imaging biomarkers and skin gene expression subsetting in dasatinib treatment of systemic sclerosis-associated interstitial lung disease. PLoS One. 2017 Nov 9;12(11):e0187580. doi: 10.1371/journal.pone.0187580. eCollection 2017.
Related Links
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Investigator Inquiry form
Other Identifiers
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CA180-267
Identifier Type: -
Identifier Source: org_study_id