A Neoadjuvant Pharmacodynamic Study Of RO4929097 (RO) in Pancreas Cancer
I. To evaluate the effects of neoadjuvant gamma-secretase inhibitor RO4929097 on Notch
inhibition via interrogation of Hes-1 expression in patients with pancreatic cancer.
I. To evaluate the effects of this regimen on pancreatic cancer stem cell self-renewal and
tumorigenesis as compared to pancreatic stem cells from controls (patients who do not
II. To evaluate the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10 in the
absence of disease progression or unacceptable toxicity. Beginning 7 days after completion
of gamma-secretase inhibitor RO4929097, patients undergo complete resection comprising
pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy based on the
anatomic location of the cancer. Tumor tissue from biopsy and surgery and blood samples are
collected periodically for pharmacodynamic studies.
After completion of study therapy, patients are followed up every 6 months for 1 year.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Notch activity (expression of Hes-1)
Summarized as a binary endpoint for both the RO4929097 population and the stage-matched controls by the proportion and 95% exact binomial confidence interval.
Up to day 3 (of course 1)
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|City of Hope Medical Center||Duarte, California 91010|
|Tower Cancer Research Foundation||Beverly Hills, California 90211|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|