Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00474812
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : December 23, 2013
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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
Withdrawal by Subject                5 
No Initiation of treatment                2 

  Baseline Characteristics

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 
Overall Participants Analyzed 
[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

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

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

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00474812     History of Changes
Other Study ID Numbers: NCI-2009-00228
NCI-2009-00228 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 5206
CASE 5206 ( Other Identifier: Case Western Reserve University )
7828 ( Other Identifier: CTEP )
U01CA062502 ( U.S. NIH Grant/Contract )
First Submitted: May 16, 2007
First Posted: May 17, 2007
Results First Submitted: July 31, 2013
Results First Posted: December 23, 2013
Last Update Posted: May 5, 2015