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
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation
ClinicalTrials.gov Identifier: NCT00327223     History of Changes
Other Study ID Numbers: AMP-011
Study First Received: May 17, 2006
Last Updated: March 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by AmpliMed Corporation:
Metastatic cancer
Disseminated malignant disease

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

ClinicalTrials.gov processed this record on August 26, 2014