Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis

Completed · Phase 1/Phase 2

Conditions studied: Scleroderma

In brief

The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.

Key facts

Study ID

NCT00764309

Run by

Bristol-Myers Squibb

People needed

47

Starts

2009-01-01

Expected to finish

2011-04-01

Last updated by the study team

2012-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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