Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: May 16, 2007
Last updated: February 21, 2014
Last verified: November 2013
Results First Received: July 31, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions: Drug: dasatinib
Procedure: laboratory biomarker analysis
Procedure: physiologic testing

  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
Patients were recruited from Cleveland, Ohio area hospitals, Case Medical Center University Hospitals and MetroHealth Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Dasatinib Treatment Patients receive oral dasatinib twice daily on days 1-28.

Participant Flow:   Overall Study
    Dasatinib Treatment  
STARTED     51  
COMPLETED     44  
Withdrawal by Subject                 5  
No Initiation of treatment                 2  

  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
Dasatinib Treatment Patients receive oral dasatinib twice daily on days 1-28.

Baseline Measures
    Dasatinib Treatment  
Number of Participants  
[units: participants]
[units: years]
Median ( Full Range )
  ( 43 to 80 )  
[units: participants]
Female     34  
Male     17  
Race (NIH/OMB)  
[units: participants]
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     46  
More than one race     0  
Unknown or Not Reported     1  
Region of Enrollment  
[units: participants]
United States     51  

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Overall Survival   [ Time Frame: assessed up to 24 months ]

2.  Secondary:   Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee   [ Time Frame: Up to 5 years ]

3.  Secondary:   Median Progression Free Survival (PFS)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Gait Speed   [ Time Frame: baseline ]

5.  Secondary:   Gait Speed   [ Time Frame: at 8 weeks ]

  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Charles Nock MD
Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
phone: 216-844-3862

No publications provided

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00474812     History of Changes
Other Study ID Numbers: NCI-2009-00228, NCI-2009-00228, CDR0000546554, CASE 5206, CASE 5206, 7828, U01CA062502
Study First Received: May 16, 2007
Results First Received: July 31, 2013
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration