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Rollover Study Of Lapatinib In Cancer Patients

NCT ID: NCT00169533

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-19

Study Completion Date

2009-05-05

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms, Breast

Keywords

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safety tolerating lapatinib Lapatinib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Lapatinib either 750, 1000, 1250 or 1500 mgs

Group Type EXPERIMENTAL

GW572016 oral tablets

Intervention Type DRUG

Lapatinib either at 750, 1000, 1250 or 1500 mgs

Interventions

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GW572016 oral tablets

Lapatinib either at 750, 1000, 1250 or 1500 mgs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Detroit, Michigan, United States

Site Status

GSK Investigational Site

Lebanon, New Hampshire, United States

Site Status

GSK Investigational Site

Albuquerque, New Mexico, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Durham, North Carolina, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Edmonton, Alberta, Canada

Site Status

GSK Investigational Site

Tel Aviv, , Israel

Site Status

Countries

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South Korea United States Canada Israel

Other Identifiers

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EGF19060

Identifier Type: -

Identifier Source: org_study_id