A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer
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.
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients alive at 6 months
If patients are lost to follow-up prior to the time required for the applicable primary endpoint, we will consider reporting the final point estimate of the primary endpoint via the method of Kaplan and Meier (1958) which accounts for the censoring of such data at the date of last contact (last known alive). Otherwise, ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Up to 6 months
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|
|Wayne State University||Detroit, Michigan 48202|