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

AmpliMed

Status and phase: Completed; Phase 1

Conditions: Neoplasm Metastasis

Treatments: Drug: imexon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327223

AMP-011

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

imexon

Experimental group

Description:

Dose escalation of imexon

Treatment:

Drug: imexon