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Dasatinib in Treating Patients With Previously Treated Malignant Mesothelioma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00509041
First received: July 30, 2007
Last updated: July 11, 2016
Last verified: July 2016
Results First Received: December 11, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Mesothelioma
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
Between September 2007 to August 2009, 46 participants were recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three (3) participants withdrew from the study before treatment initiation; therefore 43 participants were eligible for evaluation

Reporting Groups
  Description
Dasatinib Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma

Participant Flow:   Overall Study
    Dasatinib
STARTED   43 
COMPLETED   43 
NOT COMPLETED   0 



  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
Dasatinib Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma

Baseline Measures
   Dasatinib 
Overall Participants Analyzed 
[Units: Participants]
 43 
Age 
[Units: Years]
Median (Full Range)
 68 
 (35 to 81) 
Gender 
[Units: Participants]
 
Female   12 
Male   31 
Region of Enrollment 
[Units: Participants]
 
United States   43 
ECOG Performance Score [1] 
[Units: Participants]
 
0 - Fully Active   19 
1 - Ambulatory, restricted strenuous activity   24 
[1] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).
Site of origin 
[Units: Participants]
 
Pleura   36 
Peritoneum   6 
Other   1 
Histology 
[Units: Participants]
 
Epithelial   33 
Biphasic   5 
Sarcomatoid   2 
Not reported   3 
Prior chemotherapy 
[Units: Participants]
 
Yes   43 
No   0 
Prior radiation 
[Units: Participants]
 
Yes   6 
No   37 
Prior surgery 
[Units: Participants]
 
Yes   23 
No   20 


  Outcome Measures
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1.  Primary:   24 Week Progression Free Survival   [ Time Frame: 24 weeks ]

2.  Secondary:   Number of Participants With Overall Tumor Response   [ Time Frame: Duration of study until progression (up to 3 years) ]

3.  Secondary:   Overall Survival   [ Time Frame: Time from registration to death (up to 3 years) ]

4.  Secondary:   Progression Free Survival   [ Time Frame: Time from registration to progression or death (up to 3 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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Arkadiusz Dudek, MD, PhD
Organization: University of Minnesota Masonic Cancer Center
e-mail: dudek002@umn.edu


Publications of Results:
Dudek A, Pang H, Kratzke RA, et al.: CALGB 30601: A phase II study of dasatinib (D) in patients (pts) with previously treated malignant mesothelioma (MM). [Abstract] J Clin Oncol 28 (Suppl 15) A-7037, 2010.


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00509041     History of Changes
Other Study ID Numbers: CALGB-30601
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000558362 ( Registry Identifier: NCI Physician Data Query )
Study First Received: July 30, 2007
Results First Received: December 11, 2012
Last Updated: July 11, 2016