At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating imexon in combination with gemcitabine and imexon placebo + gemcitabine for Pancreatic Neoplasms. Completed, enrolled 142 participants across 48 sites.
Detailed 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.
Study Details
Timeline
Interventions
875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV
imexon placebo IV + 1000 mg/m\^2 gemcitabine IV