Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

Completed · Phase 2

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

In brief

This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00735917

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2008-10-01

Expected to finish

2012-10-01

Last updated by the study team

2019-04-02

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
• Received ≥ 1 prior chemotherapy regimen, preferably gemcitabine hydrochloride-based
• Biomarker screening portion of study:
• For subjects without archival tissue available (core biopsy or resection specimen; fine-needle aspirate samples only are not sufficient), must be willing to undergo a fresh needle-core biopsy of a safely biopsiable metastasis
• No known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• White blood cell (WBC) ≥ 3,000/mm³
• Absolute neutrophil count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin < 1.5 times upper normal limit (ULN) (patients may have been shunted in order to achieve normal bilirubin level)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 times ULN (< 5 times ULN for patients with liver metastases)
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Urine protein < 1,000 mg
• Urine protein: creatinine ratio ≤ 1.0
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Asymptomatic human immunodeficiency virus (HIV) allowed
• Willingness to undergo 2 tumor biopsies
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
• No prolonged QTc interval (i.e., ≥ 480 msec)
• No other significant electrocardiogram (ECG) abnormalities
• No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm Hg or diastolic BP ≥ 90 mm Hg)

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• University of Colorado at Denver — Aurora, Colorado, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• National University Hospital — Singapore, Singapore

Full record on ClinicalTrials.gov

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