Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00764309
First received: October 1, 2008
Last updated: January 30, 2012
Last verified: January 2012
Results First Received: January 30, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Scleroderma
Intervention: Drug: dasatinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 47 participants enrolled, 31 were treated. Reasons for not entering treatment period were: withdrew consent-1, lost to follow up-2, no longer met study criteria-12, other reasons-1.

Reporting Groups
  Description
100 mg Dasatinib, Oral Administration Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)

Participant Flow:   Overall Study
    100 mg Dasatinib, Oral Administration  
STARTED     31 [1]
COMPLETED     31 [2]
NOT COMPLETED     0  
[1] Number of participants treated.
[2] Completed=off study. Major Reasons for off study: AE-13; withdrawn by sponsor-10; Lack of efficacy-3



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
100 mg Dasatinib, Oral Administration Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)

Baseline Measures
    100 mg Dasatinib, Oral Administration  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Mean ± Standard Deviation
  50.8  ± 12.44  
Age, Customized  
[units: Years]
 
<65 years     26  
>=65 years     5  
Gender  
[units: participants]
 
Female     21  
Male     10  
Race/Ethnicity, Customized  
[units: participants]
 
White     24  
Black / African American     3  
American Indian/Alaska Native     1  
Other     3  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic/Latino     3  
Not Hispanic/Latino     28  
Baseline Pulmonary Function: Diffusion capacity [1]
[units: mL/min/mmHg]
Mean ± Standard Deviation
  14.223  ± 4.8012  
Baseline Pulmonary Function [2]
[units: Liters]
Mean ± Standard Deviation
 
FVC, n=30     2.955  ± 0.7978  
FEV1, n=30     2.614  ± 1.3495  
TLC, n=26     4.292  ± 1.1784  
Time from Initial Scleroderma Diagnosis to Start of Study  
[units: Participants]
 
< 12 months     12  
12 - 23 months     8  
24 - 36 months     7  
> 36 months     4  
[1]

Diffusing capacity (DLCO) is the carbon monoxide uptake from a single inspiration in a standard time (usually 10 sec).

There were 29 participants with observations for this measure.

[2]

Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration; Forced expiratory volume in 1 second (FEV1) is volume that has been exhaled at the first second of forced expiration; Total lung capacity (TLC) is the maximum volume of air present in the lungs.

n=participants with observations




  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00764309     History of Changes
Other Study ID Numbers: CA180-267
Study First Received: October 1, 2008
Results First Received: January 30, 2012
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration