Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00764309

Purpose

The purpose of this study is to see if dasatinib, with its known side effects, is safe to use in patients with scleroderma pulmonary fibrosis

Condition	Intervention	Phase
Scleroderma	Drug: dasatinib	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Pulmonary Fibrosis Scleroderma

Drug Information available for: Dasatinib

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Incidence of pleural or pericardial effusions [ Time Frame: Continuously ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	January 2009
Study Completion Date:	April 2011
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1	Drug: dasatinib Tablets, Oral, 100 mg, once daily, 6 months Other Names: Sprycel BMS 354825

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Target Population

meet 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 FVC between 45% and 80% of predicted normal and/or DLCO between 30% and 70% of predicted normal values
have an abnormal high resolution 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 ECG

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, ALT or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764309

Locations

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

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00764309 History of Changes
Other Study ID Numbers:	CA180-267
Study First Received:	October 1, 2008
Last Updated:	October 31, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Fibrosis
Pulmonary Fibrosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

Lung Diseases
Respiratory Tract Diseases
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012