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

AmpliMed

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Melanoma

Treatments: Drug: imexon; Drug: DTIC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327600

AMP-005

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

imexon + DTIC

Experimental group

Treatment:

Drug: DTIC

Drug: imexon