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NCT00637247 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by AmpliMed Corporation.

Completed
Registry status
Phase 2
Development phase
142
Enrollment target

NCT00637247: Completed Phase 2 study, sponsored by AmpliMed Corporation.

NCT00637247 is a Phase 2 study that has completed, run by AmpliMed Corporation. The registered enrollment target is 142 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00637247, a Phase 2 study, has completed, sponsored by AmpliMed Corporation.

COMPLETED
Registry status
Phase 2
Development phase
142 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG imexon in combination with gemcitabine
  • DRUG imexon placebo + gemcitabine

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2008-04
Est. Completion 2010-06
Phase Phase 2
AmpliMed Corporation

6 total trials

What the finished NCT00637247 record still lists

NCT00637247 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which imexon in combination with gemcitabine is the first listed.

NCT00637247 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00637247 about?

NCT00637247 is a clinical study titled "A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer". 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...

What is the current status of trial NCT00637247?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2008-04. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00637247?

The interventions under investigation include: imexon in combination with gemcitabine (DRUG), imexon placebo + gemcitabine (DRUG).

Who is sponsoring clinical trial NCT00637247?

This trial is sponsored by AmpliMed Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00637247's enrollment target sits among peer trials

142 507th of 2000 higher than 1,491 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00637247, the US trial registry maintained by the National Library of Medicine. NCT00637247 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.