Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
The purpose of this study was to evaluate the safety of Dasatininb in the treatment of
 scleroderma pulmonary interstitial fibrosis.
Inclusion Criteria:

 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 Criteria:

 -  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