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

Neoplasm Metastasis Clinical Trial

Official title:

A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327223
• Other study ID #: AMP-011
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2006
• Last updated: March 12, 2008
• Start date: November 2005
• Est. completion date: October 2006

Study information

• Verified date: March 2008
• Source: AmpliMed Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• imexon

Locations

Country	Name	City	State
United States	US Oncology Albany, New York Oncology	Albany	New York
United States	US Oncology Indiana	Indianapolis	Indiana
United States	Investigational Site 014	Temple	Texas
United States	US Oncology, Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AmpliMed Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximally tolerated dose			Yes
Primary	determine the pharmacokinetics			No
Primary	determine the toxicity of the drug on the designated schedule			Yes