Phase I Study of CellCept for Advanced Pancreatic Cancer
Mycophenolate Mofetil (CellCept) is a prodrug whose active metabolite, mycophenolic acid
(MPA), acts as an immune suppressant by inhibiting de novo guanosine synthesis. CellCept is
FDA approved to prevent rejection of transplanted organs. It is well tolerated, orally
dosed, and has some known antitumor effects. It has never been studied in pancreatic cancer
and the maximum tolerated dose is not known. In vitro studies in our lab with human
pancreatic cancer lines found that MPA was a potent inhibitor of pancreatic cancer cell
growth and induced apoptosis. The objectives of this study are to identify the maximum
tolerated dose of CellCept in patients with advanced pancreatic cancer that have failed at
least two prior chemotherapy regimens and assess its pharmacokinetics.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer
8 weeks
Yes
Robert L Fine, MD
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAA1127
NCT00997958
June 2004
January 2009
Name | Location |
---|---|
Columbia University Medical Center | New York, New York 10032 |