NCT00169533

Brief Summary

The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_1

Geographic Reach
3 countries

12 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

August 19, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2009

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

4.7 years

First QC Date

September 9, 2005

Last Update Submit

November 13, 2017

Conditions

Neoplasms, Breast

Keywords

safetytolerating lapatinibLapatinib

Outcome Measures

Primary Outcomes (1)

  • To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen

    Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

Secondary Outcomes (1)

  • Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival

    Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

Study Arms (1)

Arm 1

EXPERIMENTAL

Lapatinib either 750, 1000, 1250 or 1500 mgs

Drug: GW572016 oral tablets

Interventions

GW572016 oral tabletsDRUG

Lapatinib either at 750, 1000, 1250 or 1500 mgs

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen.
  • Ability to understand and provide written informed consent to participate in this trial.
  • Is male or female.
  • Female and male subjects agree to the protocol specific birth control measures

You may not qualify if:

  • Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
  • Is a pregnant or lactating female.
  • Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
  • Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2).
  • Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  • Has a left ventricular ejection fraction (LVEF) \< 40% based on MUGA or ECHO.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Detroit, Michigan, 48201, United States

Location

GSK Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87131, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

GSK Investigational Site

Tel Aviv, 64239, Israel

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

September 9, 2005

First Posted

September 15, 2005

Study Start

August 19, 2004

Primary Completion

May 5, 2009

Study Completion

May 5, 2009

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

US(10)CA(1)IL(1)