NCT00637247

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

A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: AmpliMed Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	imexon in combination with gemcitabine	875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV
DRUG	imexon placebo + gemcitabine	imexon placebo IV + 1000 mg/m\^2 gemcitabine IV

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2008-03-17
• Last updated: 2019-03-20
• Results posted: 2010-11-30

Locations

48 sites across 1 country: United States