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

March 12, 2008 updated by: AmpliMed Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • US Oncology Indiana
    • New York
      • Albany, New York, United States, 12208
        • US Oncology Albany, New York Oncology
    • Texas
      • Temple, Texas, United States, 76508
        • Investigational Site 014
      • Tyler, Texas, United States, 75702
        • US Oncology, Tyler Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: imexon
Dose escalation of imexon
Drug: imexon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine the maximally tolerated dose
determine the pharmacokinetics
determine the toxicity of the drug on the designated schedule

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AmpliMed Corporation

Investigators

  • Study Director: Evan Hersh, MD, AmpliMed Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

March 14, 2008

Last Update Submitted That Met QC Criteria

March 12, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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