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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 is a Phase 1 study that has completed, run by AmpliMed Corporation. The registered enrollment target is 68 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00327600
The ClinicalTrials.gov registry entry for NCT00327600 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AmpliMed Corporation, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which imexon is the first listed.
NCT00327600 reports 0 study locations.
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.
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