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Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma

NCT00327600 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2010-09-15

No results posted yet for this 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.

Conditions

  • Malignant Melanoma

Interventions

DRUG

imexon

DRUG

DTIC

Sponsors & Collaborators

  • AmpliMed Corporation

    lead INDUSTRY

Principal Investigators

  • Evan Hersh, MD · AmpliMed Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-01-31
Completion
2007-12-31

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 NCT00327600 on ClinicalTrials.gov