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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327223
First Posted: May 18, 2006
Last Update Posted: March 14, 2008
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.
Information provided by:
AmpliMed Corporation
  Purpose
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 Intervention Phase
Neoplasm Metastasis Drug: imexon Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:
  • Determine the maximally tolerated dose
  • determine the pharmacokinetics
  • determine the toxicity of the drug on the designated schedule

Enrollment: 18
Study Start Date: November 2005
Study Completion Date: October 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: imexon
Dose escalation of imexon
Drug: imexon

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation
ClinicalTrials.gov Identifier: NCT00327223     History of Changes
Other Study ID Numbers: AMP-011
First Submitted: May 17, 2006
First Posted: May 18, 2006
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


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