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Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia

NCT00497809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2011-05-03

No results posted yet for this study

Summary

The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor \[G-CSF\]) in breast cancer patients at high (\>20%) risk for chemotherapy-induced severe neutropenia.

Conditions

Interventions

DRUG

AVI-014 versus Filgrastim

3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily

Sponsors & Collaborators

  • AviGenics

    lead INDUSTRY

Principal Investigators

  • Howard Ozer, MD · University of Oklahoma

  • Robert J. Grieve, M.B,Ch.B., FRCR · University Hospitals of Coventry and Warwickshire

  • Walter Kraft, MD, MS, FACP · AviGenics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-07-31
Completion
2009-07-31

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT00497809 on ClinicalTrials.gov