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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00327223
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : March 14, 2008
Sponsor:
Information provided by:
AmpliMed Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Drug: imexon Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Primary Completion Date : September 2006
Study Completion Date : October 2006

Arm Intervention/treatment
Experimental: imexon
Dose escalation of imexon
Drug: imexon



Primary Outcome Measures :
  1. Determine the maximally tolerated dose
  2. determine the pharmacokinetics
  3. determine the toxicity of the drug on the designated schedule


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327223


Locations
United States, Indiana
US Oncology Indiana
Indianapolis, Indiana, United States, 46227
United States, New York
US Oncology Albany, New York Oncology
Albany, New York, United States, 12208
United States, Texas
Investigational Site 014
Temple, Texas, United States, 76508
US Oncology, Tyler Cancer Center
Tyler, Texas, United States, 75702
Sponsors and Collaborators
AmpliMed Corporation
Investigators
Study Director: Evan Hersh, MD AmpliMed Corporation

Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation
ClinicalTrials.gov Identifier: NCT00327223     History of Changes
Other Study ID Numbers: AMP-011
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: March 14, 2008
Last Verified: March 2008

Keywords provided by AmpliMed Corporation:
Metastatic cancer
Disseminated malignant disease

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes