GW572016 In Patients With Advanced Or Metastatic Breast Cancer

August 30, 2018 updated by: GlaxoSmithKline

Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer

This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

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

        • GSK Investigational Site
  • Japan
      • Ehime, Japan, 791-0280
        • GSK Investigational Site
      • Fukuoka, Japan, 802-0077
        • GSK Investigational Site
      • Kanagawa, Japan, 241-0815
        • GSK Investigational Site
      • Saitama, Japan, 350-1298
        • GSK Investigational Site
      • Tochigi, Japan, 320-0834
        • GSK Investigational Site
      • Tokyo, Japan, 104-0045
        • GSK Investigational Site
      • Tokyo, Japan, 135-8550
        • GSK Investigational Site
      • Tokyo, Japan, 113-8677
        • 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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
  • Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
  • Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria:

  • Patients with certain heart problems.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lapatinib 1500mg daily
Subjects will self-administer lapatinib 1500 mg orally once daily.
Drug: Tykerb
lapatinib 1500mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016

Secondary Outcome Measures

Outcome Measure
Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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 (Actual)

June 30, 2004

Primary Completion (Actual)

December 20, 2006

Study Completion (Actual)

December 20, 2006

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGF100642

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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