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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. 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

Brief Summary:

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with stage IV pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: dasatinib Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: quality-of-life assessment Phase 2

Detailed Description:



  • To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV pancreatic cancer treated with dasatinib.


  • To evaluate the response rate (complete and partial response) in patients treated with this drug.
  • To evaluate the median PFS and overall survival of patients treated with this drug.
  • To study the toxicities and tolerability of this drug in these patients.
  • To evaluate the impact of this drug on quality of life measures.
  • To evaluate the impact of this drug on Src and FAK in peripheral blood mononuclear cells prior to and during treatment.
  • To study the pre-treatment expression of various signaling molecules in the Src and STAT3 pathways and attempt to identify a relationship between these findings and the aggressiveness of the tumor or its response to treatment with dasatinib.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative and biological studies. Blood samples are analyzed for phosphorylation levels of proteins, including phospho-Src, phospho-Fak, and other relevant biomarkers, by western blotting. Tumor tissue samples are analyzed for biomarkers by immunohistochemistry.

Quality of life is assessed at baseline, after every other course during treatment, and then at 1 year after treatment using the FACT-HEP questionnaire.

After completion of study treatment, patients are followed every 2 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Dasatinib in Patients With Metastatic Pancreatic Cancer
Study Start Date : September 2007
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dasatinib

Arm Intervention/treatment
Experimental: Dasatinib
Dasatinib 70 mg po bid (1 cycle=28 days)
Drug: dasatinib
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically* confirmed pancreatic cancer

    • Stage IV disease NOTE: *If biopsy was performed at an outside facility, the histology must be reviewed and confirmed by the Division of Pathology at the City of Hope


  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 3 months
  • Platelet count ≥ 100,000/μL
  • Absolute neutrophil count ≥ 1,500/μL
  • Bilirubin ≤ 1.5 mg/dL
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 mg/dL and/or creatinine clearance > 60 mL/min
  • PT and PTT ≤ 1.5 times ULN
  • Able to swallow dasatinib whole
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder
  • No concurrent medical condition which may increase the risk of toxicity, including any of the following:

    • Pleural or pericardial effusion of any grade
    • Clinically significant coagulation or platelet function disorder (e.g., known von Willebrand's disease)
  • None of the following cardiac conditions:

    • Uncontrolled angina, congestive heart failure, or myocardial infarction within the past 6 months
    • Prolonged QTc interval (i.e., QTc > 450 msec) on electrocardiogram
    • History of clinically significant ventricular arrhythmias (i.e., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • No hypokalemia or hypomagnesemia that cannot be corrected
  • No severe infection requiring treatment
  • Completely recovered from other concurrent illnesses, as deemed by the investigator
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception


  • Recovered from prior major surgery
  • No prior irradiation to the planned field
  • No prior chemotherapy for pancreatic cancer
  • At least 7 days since prior and no concurrent medications that may prolong the QT interval, including any of the following:

    • Quinidine
    • Procainamide
    • Disopyramide
    • Amiodarone
    • Sotalol
    • Ibutilide
    • Dofetilide
    • Erythromycin
    • Clarithromycin
    • Chlorpromazine
    • Haloperidol
    • Mesoridazine
    • Thioridazine
    • Pimozide
    • Cisapride
    • Bepridil
    • Droperidol
    • Methadone
    • Arsenic
    • Chloroquine
    • Domperidone
    • Halofantrine
    • Levomethadyl
    • Pentamidine
    • Sparfloxacin
    • Lidoflazine
  • At least 7 days since prior and no concurrent potent CYP3A4 inhibitors
  • At least 7 days since prior and no concurrent medications that directly and durably inhibit platelet function, including any of the following:

    • Aspirin or aspirin-containing combinations
    • Clopidogrel
    • Dipyridamole
    • Tirofiban
    • Dipyridamole
    • Epoprostenol
    • Eptifibatide
    • Cilostazol
    • Abciximab
    • Ticlopidine
    • Cilostazol
  • No concurrent anticoagulants, including warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin)

    • Low-dose warfarin for prophylaxis to prevent catheter thrombosis or heparin for flushes of IV lines allowed
  • No concurrent IV bisphosphonates during the first 8 weeks of dasatinib therapy
  • No concurrent Hypericum perforatum (St. Johns wort)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544908

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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
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Principal Investigator: Vincent Chung, MD City of Hope Comprehensive Cancer Center
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Responsible Party: City of Hope Medical Center Identifier: NCT00544908    
Other Study ID Numbers: 07024
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000570288 ( Registry Identifier: NCI PDQ )
First Posted: October 16, 2007    Key Record Dates
Results First Posted: September 17, 2015
Last Update Posted: October 5, 2015
Last Verified: September 2015
Keywords provided by City of Hope Medical Center:
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action