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

This study has been completed.
Sponsor:
Information provided by:
AmpliMed Corporation
ClinicalTrials.gov Identifier:
NCT00327223
First received: May 17, 2006
Last updated: March 12, 2008
Last verified: March 2008

May 17, 2006
March 12, 2008
November 2005
September 2006   (final data collection date for primary outcome measure)
  • Determine the maximally tolerated dose [ Designated as safety issue: Yes ]
  • determine the pharmacokinetics [ Designated as safety issue: No ]
  • determine the toxicity of the drug on the designated schedule [ Designated as safety issue: Yes ]
  • Determine the maximally tolerated dose
  • determine the pharmacokinetics
  • determine the toxicity of the drug on the designated schedule.
Complete list of historical versions of study NCT00327223 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm Metastasis
Drug: imexon
Experimental: imexon
Dose escalation of imexon
Intervention: Drug: imexon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
October 2006
September 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00327223
AMP-011
No
Evan Hersh, VP Medical Affairs, AmpliMed Corporation
AmpliMed Corporation
Not Provided
Study Director: Evan Hersh, MD AmpliMed Corporation
AmpliMed Corporation
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP