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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
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
Six Month Survival
The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.
Time frame: Up to 6 months
Overall Survival
Overall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
Time frame: Up to 2 years
Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])
A confirmed tumor response is defined to be a CR or PR noted as\> the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)\> \> Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to \<1.0 centimeters.\> \> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters.
Time frame: Evaluated using the first 6 courses of treatment
Duration of Response
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.
Time frame: From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years
Progression-Free Survival
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Optional correlative studies
Optional correlative studies
Optional correlative studies
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
Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.
Time frame: Progression and survival status assessed every month, up to 2 years