NCT00327600

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

A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: AmpliMed Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	imexon
DRUG	DTIC

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-01-01
• Completion: 2007-12-01
• First posted: 2006-05-18
• Last updated: 2010-09-15

Locations

11 sites across 1 country: United States