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Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas


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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median overall survival

Outcome Description:

The probability of overall survival will be estimated by Kaplan-Meier method. The estimated median survival will be compared to those reported in the literature.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Charles Nock

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Case Western Reserve University Cleveland, Ohio  44106