Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
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ClinicalTrials.gov Identifier: NCT00764309 |
Recruitment Status
:
Completed
First Posted
: October 2, 2008
Results First Posted
: February 29, 2012
Last Update Posted
: February 29, 2012
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Tracking Information | ||||
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First Submitted Date ICMJE | October 1, 2008 | |||
First Posted Date ICMJE | October 2, 2008 | |||
Results First Submitted Date | January 30, 2012 | |||
Results First Posted Date | February 29, 2012 | |||
Last Update Posted Date | February 29, 2012 | |||
Study Start Date ICMJE | January 2009 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Incidence of pleural or pericardial effusions [ Time Frame: Continuously ] | |||
Change History | Complete list of historical versions of study NCT00764309 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis | |||
Official Title ICMJE | An Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial Fibrosis | |||
Brief Summary | The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Scleroderma | |||
Intervention ICMJE | Drug: dasatinib
Tablets, Oral, 100 mg, once daily, 6 months
Other Names:
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Study Arms | Experimental: A1
Intervention: Drug: dasatinib |
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Publications * | Martyanov V, Kim GJ, Hayes W, Du S, Ganguly BJ, Sy O, Lee SK, Bogatkevich GS, Schieven GL, Schiopu E, Marangoni RG, Goldin J, Whitfield ML, Varga J. Novel lung imaging biomarkers and skin gene expression subsetting in dasatinib treatment of systemic sclerosis-associated interstitial lung disease. PLoS One. 2017 Nov 9;12(11):e0187580. doi: 10.1371/journal.pone.0187580. eCollection 2017. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
47 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date | April 2011 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Target Population
Exclusion Criteria:
Laboratory Test Findings
Prohibited Treatments and/or Therapies
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00764309 | |||
Other Study ID Numbers ICMJE | CA180-267 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bristol-Myers Squibb | |||
Study Sponsor ICMJE | Bristol-Myers Squibb | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bristol-Myers Squibb | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |