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Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764309
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : February 29, 2012
Last Update Posted : February 29, 2012
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Scleroderma Drug: dasatinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial Fibrosis
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: A1 Drug: dasatinib
Tablets, Oral, 100 mg, once daily, 6 months
Other Names:
  • Sprycel
  • BMS 354825

Primary Outcome Measures :
  1. Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs) [ Time Frame: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years ]
    AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.

  2. Reasons for Discontinuation of Study Treatment [ Time Frame: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years ]

    Participants who discontinued the study due to any AEs were recorded.

    Significant drug-related discontinuations were those SAEs recorded on the SAE case report forms with relationship to study drug of related or missing and action taken regarding study drug of discontinued or missing.

  3. Laboratory Test Results Summary of Toxicity: Hematology [ Time Frame: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years ]
    Toxicity was graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. (Grade (GR)0=normal, GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening). Granulocyte count (x 10^9 /L), GR1: ≥1.0 - <1.5, GR2: ≥0.5 - <1.0; Hemoglobin (g/dL), GR0: 13-17, GR1: <13 - 10.0 , GR2: 8.0 - <10.0, GR3: 6.5 - <8.0; Platelet count (x 10^9 /L) GR0: 150-400, GR2: ≥50.0 - <75.0; Leukocyte count (x 10^9 /L ), GR0: 3.5-11.1, GR2: 2.0 - <3.0.

  4. Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR) [ Time Frame: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years ]
    GR0=normal,1=mild,2=moderate,3=severe,4=life-threatening. ALP(U/L) GR0:40-135,GR1:>135-337; ALT(U/L) GR0:0-47,GR1:>47-117; AST(U/L) GR0:0-37,GR1:>37-93; High(↑) Calcium(mg/dL) GR0:8.4-10.2,GR1:>10.2-11.5; Low(↓) Calcium(mg/dL) GR0:8.4-10.2,GR1:<8.4-8.0,GR2:7.0-<8.0; CK(U/L) GR0:24-195,GR1:>195-488, GR2:>488-975; Creatinine(mg/dL) GR0:0.6-1.4,GR1:>1.4-2.1,GR2:>2.1-4.2; ↑Potassium(mEq/L) GR0:3.6-5.2,GR1:>5.2-5.5,GR2:>5.5-6.0; ↑Sodium(mEq/L) GR0:134-146; ↓Sodium(mEq/L) GR0:134-146,GR1:<134-130; Inorganic Phosphorus(mg/dL) GR0:2.4-4.9,GR2:≥2.0-<2.5; Total Bilirubin(mg/dL) GR0:0-1.1,GR1:>1.1-2.75.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764309

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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Ucla Division Of Rheumatology
Los Angeles, California, United States, 90095
United States, Connecticut
University Of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston University School Of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48106
West Michigan Rheumatology
Grand Rapids, Michigan, United States, 49546
United States, New Jersey
Umdnj Clinical Research Center
New Brunswick, New Jersey, United States, 08903
United States, New York
Hospital For Special Surgery
New York, New York, United States, 10021
United States, Pennsylvania
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb Identifier: NCT00764309    
Other Study ID Numbers: CA180-267
First Posted: October 2, 2008    Key Record Dates
Results First Posted: February 29, 2012
Last Update Posted: February 29, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action