Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Lapatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Lapatinib either 750, 1000, 1250 or 1500 mgs

Lapatinib either at 750, 1000, 1250 or 1500 mgs

GW572016 oral tablets

GSK Clinical Trials

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.

Rollover Study Of Lapatinib In Cancer Patients

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

GlaxoSmithKline

Herbal and Botanical

Trastuzumab

Orange

Lapatinib:

A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible.

The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria.

Trastuzumab:

Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals.

Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.

This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.

GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

Phase I Study of Lapatinib in Combination With Trastuzumab

To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rollover Study Of Lapatinib In Cancer Patients	NCT00169533	Neoplasms, Brea...	GW572016 oral t...	18 Years -	GlaxoSmithKline
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer	NCT00371488	Neoplasms, Brea...	GW572016 oral t...	20 Years - 74 Years	GlaxoSmithKline
Rollover Study Of Lapatinib In Cancer Patients	NCT00169533	Neoplasms, Brea...	GW572016 oral t...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for gw572016 oral tablets