Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.

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

Details

• Lead Sponsor: AmpliMed Corporation

Criteria

Inclusion Criteria:

• Previously treated malignant disease of any type.

• Prior treatment; at least one prior regimen required.

• Able to perform the activities of daily living.

• Off prior cancer therapy for at least 4 weeks.

• If female, neither pregnant nor nursing.

• Willing to use contraceptives to prevent pregnancy.

• No other serious illnesses.

• No other active malignancy.

• No serious infections.

• No other current drug therapy for the cancer.

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

• Prior radiation is permitted.

Exclusion Criteria:

• No active brain metastases.