32
Participants
Start Date
May 31, 2007
Primary Completion Date
May 31, 2009
Study Completion Date
September 30, 2009
Oral lapatinib tablets or placebo tablets
Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progression. Subjects who maintain stable disease will be randomized in a 1:1 ratio to enter stage 2 of the study and receive double blind therapy of either lapatinib 1500 mg/day orally or placebo. Subjects who progress on placebo will have the option to receive lapatinib 1500 mg/day orally until further progression. Those who progress on lapatinib will be withdrawn from the study.
GSK Investigational Site, Albany
GSK Investigational Site, Leesburg
GSK Investigational Site, Newport News
GSK Investigational Site, Raleigh
GSK Investigational Site, Greenville
GSK Investigational Site, Indianapolis
GSK Investigational Site, Minneapolis
GSK Investigational Site, St Louis
GSK Investigational Site, Overland Park
GSK Investigational Site, Dallas
GSK Investigational Site, Tyler
GSK Investigational Site, Bedford
GSK Investigational Site, Fort Worth
GSK Investigational Site, Austin
GSK Investigational Site, El Paso
GSK Investigational Site, Denver
GSK Investigational Site, Las Vegas
GSK Investigational Site, Vancouver
GSK Investigational Site, Spokane
GSK Investigational Site, Webster
Lead Sponsor
GlaxoSmithKline
INDUSTRY