Rollover Study Of Lapatinib In Cancer Patients - Full Text View

Rollover Study Of Lapatinib In Cancer Patients

This study is ongoing, but not recruiting participants.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00169533

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: GW572016 oral tablets	Phase I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

Official Title:	An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	65
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Responding and tolerating lapatinib in a previous lapatinib study.

Exclusion Criteria:

Permanent discontinuation from lapatinib in the previous study due to intolerance or treatment failure.
Pregnant or lactating female.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169533

Locations


United States, Indiana
	GSK Clinical Trials Call Center
	Indianapolis, Indiana, United States, 46202

United States, New Hampshire
	GSK Clinical Trials Call Center
	Lebanon, New Hampshire, United States, 03756

United States, North Carolina
	GSK Clinical Trials Call Center
	Chapel Hill, North Carolina, United States, 27599
	GSK Clinical Trials Call Center
	Durham, North Carolina, United States, 27710

United States, Ohio
	GSK Clinical Trials Call Center
	Cleveland, Ohio, United States, 44106

United States, Pennsylvania
	GSK Clinical Trials Call Center
	Philadelphia, Pennsylvania, United States, 19111

United States, Tennessee
	GSK Clinical Trials Call Center
	Nashville, Tennessee, United States, 37203

United States, Texas
	GSK Clinical Trials Call Center
	San Antonio, Texas, United States, 78229

Israel
	GSK Clinical Trials Call Center
	Tel-Aviv, Israel, 64239

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	EGF19060
First Received:	September 9, 2005
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00169533
Health Authority:	United States: Food and Drug Administration; Israel: Ministry of Health

Keywords provided by GlaxoSmithKline:

Lapatinib

safety

tolerating lapatinib

Study placed in the following topic categories:

Lapatinib

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008