drugset / Trial / NCT00997958

Study of CellCept for Advanced Pancreatic Cancer

NCT00997958

Phase 1 Completed 12 enrolled Columbia University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2004-06
Primary completion
2007-10
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 1.5 g Oral
Subject Mycophenolate Mofetil Small molecule 2 g Oral
Subject Mycophenolate Mofetil Small molecule 2.5 g Oral
Subject Mycophenolate Mofetil Small molecule 3 g Oral
Subject Mycophenolate Mofetil Small molecule 3.5 g Oral
Subject Mycophenolate Mofetil Small molecule 4 g Oral
Subject Mycophenolate Mofetil Small molecule 4.5 g Oral
Subject Mycophenolate Mofetil Small molecule 5 g Oral