Status:
COMPLETED
Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Scleroderma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.
Eligibility Criteria
Inclusion
- Target Population
- 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
- Clinically significant pleural or pericardial effusion in the previous 12 months: Grade 3 or 4. Patients with recent Grade I or II effusions or peripheral edema will be permitted to enter the study
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00764309
Start Date
January 1 2009
End Date
April 1 2011
Last Update
February 29 2012
Active Locations (13)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Ucla Division Of Rheumatology
Los Angeles, California, United States, 90095
3
University Of Connecticut Health Center
Farmington, Connecticut, United States, 06030
4
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007