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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
History of Changes
Results First Received: October 7, 2013  
Study Type: Interventional
Study Design: 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.
No text entered.

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) 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1

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

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

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 ]
  Show Outcome Measure 4

5.  Secondary:   Progression-Free Survival   [ Time Frame: Progression and survival status assessed every month, up to 2 years ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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.

Other Adverse Events
    Treatment (Saracatinib)
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   17/19 (89.47%) 
Blood and lymphatic system disorders   
Hemoglobin decreased † 1   
# participants affected / at risk   12/19 (63.16%) 
# events   16 
Gastrointestinal disorders   
Abdominal pain † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Diarrhea † 1   
# participants affected / at risk   4/19 (21.05%) 
# events   5 
Dry mouth † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Duodenal ulcer † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Flatulence † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Nausea † 1   
# participants affected / at risk   8/19 (42.11%) 
# events   10 
Vomiting † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   3 
General disorders   
Chills † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Fatigue † 1   
# participants affected / at risk   9/19 (47.37%) 
# events   13 
Fever † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   3 
Hepatobiliary disorders   
Hepatic failure † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Investigations   
Activated partial thromboplastin time prolonged † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Alanine aminotransferase increased † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   3 
Alkaline phosphatase increased † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Aspartate aminotransferase increased † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   3 
Bilirubin increased † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   3 
Creatinine increased † 1   
# participants affected / at risk   4/19 (21.05%) 
# events   4 
INR increased † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Leukocyte count decreased † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Lymphocyte count decreased † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Platelet count decreased † 1   
# participants affected / at risk   3/19 (15.79%) 
# events   3 
Metabolism and nutrition disorders   
Anorexia † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Blood glucose increased † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Dehydration † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Serum albumin decreased † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Serum calcium increased † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Serum potassium decreased † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   2 
Serum potassium increased † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Serum sodium decreased † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Musculoskeletal and connective tissue disorders   
Myalgia † 1   
# participants affected / at risk   5/19 (26.32%) 
# events   6 
Renal and urinary disorders   
Protein urine positive † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   2 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax † 1   
# participants affected / at risk   1/19 (5.26%) 
# events   1 
Skin and subcutaneous tissue disorders   
Rash desquamating † 1   
# participants affected / at risk   2/19 (10.53%) 
# events   4 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 10



  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



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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MAYO-MC0547
CDR0000610063
MC0547 ( Other Identifier: Mayo Clinic )
7602 ( Other Identifier: CTEP )
P30CA015083 ( U.S. NIH Grant/Contract )
N01CM62205 ( U.S. NIH Grant/Contract )
Study First Received: August 14, 2008
Results First Received: October 7, 2013
Last Updated: April 25, 2014