Clinical trialPhase 2Completed
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)
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- April 2008
- Expected end
- June 2010
- Enrollment
- 142 participants
- Sites
- 48
- Primary outcomes
- Overall Survival for the Intent to Treat Population; To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms by Comparing Adverse Events
- Sponsor
- Industry
- Results posted
- 2010-11-30
- Last update
- 20 March 2019
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival for the Intent to Treat Population [up to 2 years]. Median, months (95% Confidence Interval). Amplimexon (Imexon) + Gemcitabine (n=72): 5.2 (4.2 to 6.7); Imexon Placebo + Gemcitabine (n=70): 6.8 (4.9 to 8.5). Analysis, Amplimexon (Imexon) + Gemcitabine vs Imexon Placebo + Gemcitabine: p=0.2; Log Rank; superiority or other.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
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, participants. Imexon + Gemcitabine (n=67): 67; Placebo + Gemcitabine (n=68): 68.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rates of the Two Treatment Arms [one year]. Number, percent of responses. Amplimexon (Imexon) + Gemcitabine (n=53): 13.2; Imexon Placebo + Gemcitabine (n=55): 16.4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival [one year]. Median, months (95% Confidence Interval). Amplimexon (Imexon) + Gemcitabine (n=72): 2.8 (2.0 to 4.1); Imexon Placebo + Gemcitabine (n=70): 3.8 (2.2 to 4.7).