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

NCT00327223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2008-03-14

No results posted yet for this study

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.

Conditions

  • Neoplasm Metastasis

Interventions

DRUG

imexon

Sponsors & Collaborators

  • AmpliMed Corporation

    lead INDUSTRY

Principal Investigators

  • Evan Hersh, MD · AmpliMed Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-09-30
Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00327223 on ClinicalTrials.gov