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NCT00327600 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
A Phase 1 study, sponsored by AmpliMed Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT00327600: Completed Phase 1 study, sponsored by AmpliMed Corporation.
NCT00327600 is a Phase 1 study that has completed, run by AmpliMed Corporation. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00327600, a Phase 1 study, has completed, sponsored by AmpliMed Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
Interventions
- DRUG imexon
- DRUG DTIC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
What the finished NCT00327600 record still lists
NCT00327600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which imexon is the first listed.
NCT00327600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00327600 about?
NCT00327600 is a clinical study titled "Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma". AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whe...
What is the current status of trial NCT00327600?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2005-07. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00327600?
The interventions under investigation include: imexon (DRUG), DTIC (DRUG).
Who is sponsoring clinical trial NCT00327600?
This trial is sponsored by AmpliMed Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00327600's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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