Dasatinib in Treating Patients With Stage IV Pancreatic Cancer

This study has been terminated.
(Toxicity)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00544908
First received: October 13, 2007
Last updated: September 18, 2015
Last verified: September 2015
Results First Received: August 19, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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
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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
No text entered.

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

Participant Flow:   Overall Study
    Dasatinib  
STARTED     7  
COMPLETED     7  
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 Dasatinib 70 mg po bid (1 cycle=28 days)

Baseline Measures
    Dasatinib  
Number of Participants  
[units: participants]
  7  
Age  
[units: years]
Median (Full Range)
  61  
  (41 to 83)  
Gender  
[units: participants]
 
Female     4  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     7  



  Outcome Measures
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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
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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
Study was terminated early due to toxicity.


  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: Paul Frankel, Ph.D.
Organization: City of Hope
phone: 626-256-4673 ext 65265
e-mail: pfrankel@coh.org



Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00544908     History of Changes
Other Study ID Numbers: 07024
P30CA033572 ( US NIH Grant/Contract Award Number )
CHNMC-07024
BMS-CA180-114
CDR0000570288 ( Registry Identifier: NCI PDQ )
Study First Received: October 13, 2007
Results First Received: August 19, 2015
Last Updated: September 18, 2015
Health Authority: United States: Federal Government