Status:
COMPLETED
Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 adv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00735917
Start Date
October 1 2008
End Date
October 1 2012
Last Update
April 2 2019
Active Locations (9)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
University of Colorado at Denver
Aurora, Colorado, United States, 80045
3
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
4
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201