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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AmpliMed Corporation

Criteria

Inclusion Criteria:

• Malignant melanoma; inoperable stage III or IV disease.

• Able to perform the activities of daily living.

• A projected life expectancy of at least 4 months.

• If female, neither pregnant nor nursing.

• Willing to use contraceptives to prevent pregnancy.

• Blood cell counts and blood chemistries in or near normal range.

• Prior radiation is permitted.

• No other serious illnesses.

• No other active malignancy.

• No serious infections.

• No other current drug therapy for the cancer or steroid therapy.

Exclusion Criteria:

• No prior chemotherapy for the stage III or IV disease.

• Brain metastases