Conditions: Pancreatic Neoplasms
Keywords: pancreatic cancer metastatic chemotherapy naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: imexon + gemcitabine arm 2: Placebo in combination with gemcitabine

Interventions: intervention 1: imexon in combination with gemcitabine intervention 2: imexon placebo + gemcitabine
Intervention descriptions: intervention 1: 875 mg/m\^2 imexon IV + 1000 mg/m\^2 gemcitabine IV intervention 2: imexon placebo IV + 1000 mg/m\^2 gemcitabine IV

Protocol document: