NCT00462956

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2004

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

April 17, 2007

Last Update Submit

August 30, 2018

Conditions

Neoplasms, Breast

Keywords

lapatinibmetastatic breast cancertrastuzumab (Herceptin)Stage IV breast cancerErbB2ErbB1

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Study Arms (1)

lapatinib 1500mg daily

EXPERIMENTAL

Subjects will self-administer lapatinib 1500 mg orally once daily.

Drug: Tykerb

Interventions

TykerbDRUG

lapatinib 1500mg daily

lapatinib 1500mg daily

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with certain heart problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

GSK Investigational Site

Ehime, 791-0280, Japan

Location

GSK Investigational Site

Fukuoka, 802-0077, Japan

Location

GSK Investigational Site

Kanagawa, 241-0815, Japan

Location

GSK Investigational Site

Saitama, 350-1298, Japan

Location

GSK Investigational Site

Tochigi, 320-0834, Japan

Location

GSK Investigational Site

Tokyo, 104-0045, Japan

Location

GSK Investigational Site

Tokyo, 113-8677, Japan

Location

GSK Investigational Site

Tokyo, 135-8550, Japan

Location

GSK Investigational Site

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 19, 2007

Study Start

June 30, 2004

Primary Completion

December 20, 2006

Study Completion

December 20, 2006

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

JP(8)