Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00735917
First received: August 14, 2008
Last updated: April 25, 2014
Last verified: June 2013
Results First Received: October 7, 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: saracatinib
Other: pharmacogenomic studies
Other: pharmacological study
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Other: laboratory biomarker analysis

  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
Nineteen patients with gemcitabine-resistant metastatic pancreatic cancer were enrolled from four U.S. locations from October 2008 to January 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 19 patients accrued to this study were used to report endpoints.

Reporting Groups
  Description
Treatment (Saracatinib) Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Saracatinib)  
STARTED     19  
COMPLETED     19  
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.
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Reporting Groups
  Description
Treatment (Saracatinib) Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Saracatinib)  
Number of Participants  
[units: participants]
  19  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 34 to 78 )  
Gender  
[units: participants]
 
Female     11  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     19  
Australia     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Six Month Survival   [ Time Frame: Up to 6 months ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 2 years ]

3.  Secondary:   Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])   [ Time Frame: Evaluated using the first 6 courses of treatment ]

4.  Secondary:   Duration of Response   [ Time Frame: From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years ]

5.  Secondary:   Progression-Free Survival   [ Time Frame: Progression and survival status assessed every month, up to 2 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
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  More Information
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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: Wells A. Messersmith, M.D.
Organization: University of Colorado Cancer Center
e-mail: wells.messersmith@ucdenver.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00735917     History of Changes
Obsolete Identifiers: NCT01647035
Other Study ID Numbers: NCI-2009-00194, NCI-2009-00194, MAYO-MC0547, CDR0000610063, MC0547, 7602, P30CA015083, N01CM62205
Study First Received: August 14, 2008
Results First Received: October 7, 2013
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration