Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00474812

Run by

National Cancer Institute (NCI)

People needed

51

Starts

2007-05-01

Expected to finish

2014-02-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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