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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.
 
ClinicalTrials.gov Identifier: NCT00544908
Recruitment Status : Terminated (Toxicity)
First Posted : October 16, 2007
Results First Posted : September 17, 2015
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
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
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dasatinib
Hide Arm/Group Description Dasatinib 70 mg po bid (1 cycle=28 days)
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Dasatinib
Hide Arm/Group Description Dasatinib 70 mg po bid (1 cycle=28 days)
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants
61
(41 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Progression-free Survival (PFS) Rate at 4 Months
Hide Description Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).
Time Frame Four months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Dasatinib 70 mg po bid (1 cycle=28 days)
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Secondary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame After every two cycles, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib
Hide Arm/Group Description:
Dasatinib 70 mg po bid (1 cycle=28 days)
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Adverse Event Reporting Description Adverse events recorded over a period of 13 months.
 
Arm/Group Title Dasatinib
Hide Arm/Group Description Dasatinib 70 mg po bid (1 cycle=28 days)
All-Cause Mortality
Dasatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dasatinib
Affected / at Risk (%) # Events
Total   2/7 (28.57%)    
Gastrointestinal disorders   
Diarrhea * 1  1/7 (14.29%)  1
Nausea * 1  1/7 (14.29%)  1
Small intestinal obstruction * 1  1/7 (14.29%)  1
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile) * 1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dasatinib
Affected / at Risk (%) # Events
Total   6/7 (85.71%)    
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  5/7 (71.43%)  6
Cardiac disorders   
Sinus bradycardia * 1  1/7 (14.29%)  1
Sinus tachycardia * 1  1/7 (14.29%)  1
Eye disorders   
Vitreous hemorrhage * 1  1/7 (14.29%)  1
Gastrointestinal disorders   
Abdominal distension * 1  2/7 (28.57%)  2
Abdominal pain * 1  5/7 (71.43%)  5
Constipation * 1  2/7 (28.57%)  3
Diarrhea * 1  1/7 (14.29%)  1
Dry mouth * 1  1/7 (14.29%)  1
Flatulence * 1  1/7 (14.29%)  2
Gastritis * 1  1/7 (14.29%)  1
Ileus * 1  1/7 (14.29%)  1
Nausea * 1  3/7 (42.86%)  3
Vomiting * 1  4/7 (57.14%)  4
General disorders   
Disease progression * 1  1/7 (14.29%)  1
Edema limbs * 1  1/7 (14.29%)  1
Fatigue * 1  4/7 (57.14%)  5
Flu-like symptoms * 1  1/7 (14.29%)  1
Irritability * 1  1/7 (14.29%)  1
Injury, poisoning and procedural complications   
Radiation recall reaction (dermatologic) * 1  1/7 (14.29%)  1
Investigations   
Alanine aminotransferase increased * 1  3/7 (42.86%)  4
Alkaline phosphatase increased * 1  4/7 (57.14%)  5
Aspartate aminotransferase increased * 1  4/7 (57.14%)  5
Bilirubin increased * 1  1/7 (14.29%)  1
Creatinine increased * 1  4/7 (57.14%)  4
Lymphocyte count decreased * 1  2/7 (28.57%)  3
Weight loss * 1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Acidosis * 1  1/7 (14.29%)  1
Anorexia * 1  3/7 (42.86%)  4
Blood glucose increased * 1  2/7 (28.57%)  3
Dehydration * 1  4/7 (57.14%)  4
Serum albumin decreased * 1  2/7 (28.57%)  2
Serum calcium decreased * 1  2/7 (28.57%)  2
Serum magnesium increased * 1  1/7 (14.29%)  1
Serum phosphate decreased * 1  1/7 (14.29%)  1
Serum potassium decreased * 1  1/7 (14.29%)  1
Serum sodium decreased * 1  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/7 (14.29%)  2
Muscle weakness * 1  1/7 (14.29%)  1
Nervous system disorders   
Dizziness * 1  2/7 (28.57%)  2
Headache * 1  1/7 (14.29%)  1
Psychiatric disorders   
Confusion * 1  1/7 (14.29%)  1
Depression * 1  1/7 (14.29%)  2
Renal and urinary disorders   
Bladder hemorrhage * 1  1/7 (14.29%)  1
Reproductive system and breast disorders   
Erectile dysfunction * 1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  2/7 (28.57%)  2
Hypoxia * 1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/7 (14.29%)  1
Petechiae * 1  1/7 (14.29%)  1
Vascular disorders   
Hypotension * 1  3/7 (42.86%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-256-4673 ext 65265
EMail: pfrankel@coh.org
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00544908     History of Changes
Other Study ID Numbers: 07024
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-07024
BMS-CA180-114
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