Clinical trialPhase 1Completed
Study of CellCept for Advanced Pancreatic Cancer
Phase I Study of CellCept for Advanced Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- June 2004
- Expected end
- January 2009
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Identification of maximum tolerated dose of CellCept in patients with advanced pancreatic cancer
- Sponsor
- Other
- Results posted
- No
- Last update
- 25 April 2014
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Brief summary public domain (ClinicalTrials.gov)
Mycophenolate Mofetil (CellCept) is an FDA approved, well tolerated, oral medication used to prevent the body's immune system from attacking transplanted organs. It has never been studied in patients with pancreatic cancer but some preliminary studies have shown that it may antagonize tumor growth. The goals of this study are to find out how much of this drug can safely be taken by patients with advanced pancreatic cancer and to assess the variation of the level of the drug in the blood. Patients will take the drug twice a day at a given dose and the safety of the drug will be monitored through patient symptoms and blood tests. The disease burden will be assessed by radiographic studies at the beginning and end of the study. The patient will take the drug for a total of eight weeks.
Detailed description public domain (ClinicalTrials.gov)
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.