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OpenTrials
Completed

NCT Number: NCT00327223

Safety Study of Imexon Treatment of Patients With Metastatic 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.

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Key information

Conditions

Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

US Oncology Indiana, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

imexon

Drug

Primary outcomes

  1. Determine the maximally tolerated dose

  2. determine the pharmacokinetics

  3. determine the toxicity of the drug on the designated schedule

Sponsors and collaborators

Lead sponsor

AmpliMed Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 18, 2006
Registry last updated
Mar 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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