Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:October 2008

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A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer


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


PRIMARY OBJECTIVES:

I. To determine the 6-month survival of biomarker-positive patients with previously treated
metastatic pancreatic cancer receiving AZD0530 (saracatinib).

II. To determine the adverse events of this drug in these patients.

SECONDARY OBJECTIVES:

I. To evaluate the response rate in patients treated with this drug. II. To evaluate the
overall survival of patients treated with this drug. III. To explore the pharmacodynamic
effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and positron
emission tomography (PET) scans in a subset of patients.

OUTLINE:

Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every
28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Inclusion Criteria:

- 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)

- No concurrent cardiac dysfunction including, but not limited to, any of the
following:

- History of ischemic heart disease

- Myocardial infarction

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- No condition (e.g., gastrointestinal tract disease resulting in an inability to take
oral medication or requirement for intravenous (IV) alimentation, prior surgical
procedures affecting absorption, or active peptic ulcer disease) that impairs ability
to swallow AZD0530 tablets

- No uncontrolled concurrent illness including, but not limited to any of the
following:

- Ongoing or active infection

- Psychiatric illness or social situations that would limit compliance with study
requirements

- No other malignancy within the past 5 years, except curatively treated basal cell
carcinoma of the skin or carcinoma in situ of the cervix

- Recovered from all prior therapy (< grade 2) (excluding alopecia) administered within
the past 4 weeks

- At least 3 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)

- At least 4 weeks since prior radiotherapy

- More than 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4)-active
agents

- No ongoing adverse events (excluding alopecia) due to chemotherapy or radiotherapy
given more than 4 weeks prior to study

- No other concurrent investigational agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

- Concurrent low molecular weight heparin or full-dose coumadin allowed

- Concurrent therapeutic hematopoietic growth factors allowed
We found this trial at
6
sites
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Jacksonville, FL
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Madison, WI
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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