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

Completed · Phase 1

Conditions studied: Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00327223

Run by

AmpliMed Corporation

People needed

18

Starts

2005-11-01

Expected to finish

2006-10-01

Last updated by the study team

2008-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• No active brain metastases.

Where it is running

• US Oncology Indiana — Indianapolis, Indiana, United States
• US Oncology Albany, New York Oncology — Albany, New York, United States
• Investigational Site 014 — Temple, Texas, United States
• US Oncology, Tyler Cancer Center — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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