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

NCT00637247 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2019-03-20

Study results available
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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

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

Sponsors & Collaborators

  • AmpliMed Corporation

    lead INDUSTRY

Principal Investigators

  • Evan Hersh, MD · AmpliMed Corporation

  • Steven Cohen, MD · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637247 on ClinicalTrials.gov