Dasatinib in Treating Patients With Stage IV 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: NCT00544908
Recruitment Status : Terminated (Toxicity)
First Posted : October 16, 2007
Results First Posted : September 17, 2015
Last Update Posted : October 5, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: dasatinib
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment

  Participant Flow

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
No text entered.

Reporting Groups
Dasatinib Dasatinib 70 mg po bid (1 cycle=28 days)

Participant Flow:   Overall Study

  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 Dasatinib 70 mg po bid (1 cycle=28 days)

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (41 to 83) 
[Units: Participants]
Female   4 
Male   3 
Region of Enrollment 
[Units: Participants]
United States   7 

  Outcome Measures

1.  Primary:   Progression-free Survival (PFS) Rate at 4 Months   [ Time Frame: Four months. ]

2.  Secondary:   Response Rate   [ Time Frame: After every two cycles, up to 5 years ]

  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
Study was terminated early due to toxicity.

  More Information

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

Results Point of Contact:  
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
phone: 626-256-4673 ext 65265

Responsible Party: City of Hope Medical Center Identifier: NCT00544908     History of Changes
Other Study ID Numbers: 07024
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000570288 ( Registry Identifier: NCI PDQ )
First Submitted: October 13, 2007
First Posted: October 16, 2007
Results First Submitted: August 19, 2015
Results First Posted: September 17, 2015
Last Update Posted: October 5, 2015