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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)
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.
Details
| Lead sponsor | AmpliMed Corporation |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 142 |
| Start date | 2008-04 |
| Completion | 2010-06 |
Conditions
- Pancreatic Neoplasms
Interventions
- imexon in combination with gemcitabine
- imexon placebo + gemcitabine
Primary outcomes
- Overall Survival for the Intent to Treat Population — up to 2 years
To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment. - To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events — Adverse events were collected from the time of treatment until the participant went off study treatment, an average of 4 months
Number of Participants with Adverse Events were compared between the two arms to detect any differences in number or types of events
Countries
United States