Dasatinib in Treating Patients With Metastatic 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: NCT00474812
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : December 23, 2013
Last Update Posted : May 5, 2015
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer Drug: dasatinib Procedure: laboratory biomarker analysis Procedure: physiologic testing Phase 2

Detailed Description:


I. Determine the overall survival, including median survival, of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib.


I. Determine the effects of this drug on quantities of circulating tumor cells in these patients.

II. Determine the time to progression in patients treated with this drug. III. Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug.

IV. Evaluate the toxicity of this drug in these patients. V. Evaluate objective response rate in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

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

Patients undergo blood collection at baseline and during days 25-31. Samples are analyzed for quantification of circulating tumor cells. Patients also undergo analysis of fat-free mass and gait speed at baseline and at 1, 2, and 6 months.

After completion of study treatment, patients are followed periodically.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas
Study Start Date : May 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dasatinib

Arm Intervention/treatment
Experimental: Dasatinib Treatment
Patients receive oral dasatinib twice daily on days 1-28.
Drug: dasatinib
Other Names:
  • BMS-354825
  • Sprycel

Procedure: laboratory biomarker analysis
Correlative study

Procedure: physiologic testing
Correlative study
Other Name: study of physiologic variables

Primary Outcome Measures :
  1. Median Overall Survival [ Time Frame: assessed up to 24 months ]
    From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months

Secondary Outcome Measures :
  1. Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee [ Time Frame: Up to 5 years ]
    Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.

  2. Median Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    Number of months patients were free of disease progression, defined as < 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.

  3. Gait Speed [ Time Frame: baseline ]
    Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.

  4. Gait Speed [ Time Frame: at 8 weeks ]
    Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.

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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Metastatic disease
  • Measurable or evaluable/nonmeasurable disease
  • No known brain metastases
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • Absolute granulocyte count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin > 8.5 g/dL
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • AST and ALT =< 2.5 times ULN
  • Creatinine =< 2.0 mg/dL
  • Not pregnant or nursing
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
  • No QTc prolongation (i.e., QTc interval >= 480 msecs [Fridericia correction]) or other significant ECG abnormalities
  • LVEF normal by MUGA scan
  • No condition that impairs ability to swallow and retain dasatinib tablets, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • No clinically significant cardiovascular disease, including any of the following:

    • Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
    • Major conduction abnormality (unless a cardiac pacemaker is present)
  • Recovered from all prior therapy
  • More than 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin C) and/or radiotherapy
  • No prior chemotherapy for metastatic disease
  • More than 4 weeks since prior EGFR inhibitors (e.g., imatinib mesylate, gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)
  • No prior EGFR inhibitors that target Src kinases
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent grapefruit or grapefruit juice
  • No other concurrent anticancer agents or therapies
  • No concurrent systemic antacids (i.e., H2-receptor antagonists and proton pump inhibitors) [Locally acting antacids (e.g., Maalox, Mylanta) allowed within either 2 hours before or 2 hours after dasatinib therapy]
  • No concurrent uncontrolled illness, including, but not limited to, any of the following:

    • Ongoing or active infection
    • History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired (anti-factor VIII antibodies) disorders
    • Large pleural effusions
    • Psychiatric illness or social situation that would preclude study compliance
  • More than 7 days since prior and no concurrent CYP3A4 inducers or inhibitors
  • No other concurrent investigational agents

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): NCT00474812

United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Charles Nock Case Western Reserve University

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00474812     History of Changes
Other Study ID Numbers: NCI-2009-00228
NCI-2009-00228 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 5206
CASE 5206 ( Other Identifier: Case Western Reserve University )
7828 ( Other Identifier: CTEP )
U01CA062502 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2007    Key Record Dates
Results First Posted: December 23, 2013
Last Update Posted: May 5, 2015
Last Verified: November 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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