drugset / Trial / NCT00637247

A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

NCT00637247

Phase 2 Completed 142 enrolled AmpliMed Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.

Timeline

Start
2008-04
Primary completion
2010-05
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject imexon Small molecule 875 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications