Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

April 14, 2015 updated by: GlaxoSmithKline

An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • GSK Investigational Site
      • Los Angeles, California, United States, 90095
        • GSK Investigational Site
      • Poway, California, United States, 92064
        • GSK Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • GSK Investigational Site
      • Plantation, Florida, United States, 33324
        • GSK Investigational Site
    • Georgia
      • Savannah, Georgia, United States, 31405
        • GSK Investigational Site
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • GSK Investigational Site
      • Skokie, Illinois, United States, 60077
        • GSK Investigational Site
      • Skokie, Illinois, United States, 60076
        • GSK Investigational Site
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • GSK Investigational Site
      • Des Moines, Iowa, United States, 50309
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • GSK Investigational Site
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • GSK Investigational Site
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Greenville, North Carolina, United States, 27834
        • GSK Investigational Site
      • Hickory, North Carolina, United States, 28602
        • GSK Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • GSK Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38120
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38104
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37205
        • GSK Investigational Site
    • Texas
      • Houston, Texas, United States, 77025
        • GSK Investigational Site
    • Virginia
      • Salem, Virginia, United States, 24153
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)

  • Signed informed consent
  • No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.
  • Refractory Stage IIIb or IV breast cancer
  • HER2/neu tumor overexpression
  • Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.
  • Tumor tissue available for testing.
  • 2 weeks since treatment with Herceptin (alone or in combination).
  • Able to swallow and retain oral medication
  • Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
  • Adequate kidney and liver function
  • Adequate bone marrow function

Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.)

  • Prior regimens did not include Herceptin.
  • Pregnant or lactating.
  • Conditions that would affect absorption of an oral drug
  • Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
  • Severe cardiovascular disease or cardiac disease requiring a device.
  • Active infection.
  • Brain metastases.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or IV steroids.
  • Unresolved or unstable serious toxicity from prior therapy.
  • Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

January 3, 2003

First Submitted That Met QC Criteria

January 3, 2003

First Posted (Estimate)

January 6, 2003

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGF 20002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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