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Brief Title: Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer
Official Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer
Study ID: NCT00549328
Brief Summary: This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.
Detailed Description: Study 109609 is a single-arm, non-randomized, single-stage Phase II study of pazopanib in subjects with Stage IIIB or IV non-small cell lung cancer who have progressed after one or two prior regimens of systemic therapy. The study will be conducted at a limited number of institutions in the US. A total of 40 evaluable subjects will be enrolled and treated. Pazopanib will be given at a dose of 800mg (as determined by previous Phase I studies) orally once per day. Subjects may continue to receive study drug for up to two years unless they experience disease progression or withdraw from treatment for other reasons, or unless the Sponsor terminates the study. A rollover study may be available to those subjects who are exhibiting clinical benefit (stable disease or better). Evaluable subjects will be assessed for response as the primary endpoint.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Scottsdale, Arizona, United States
GSK Investigational Site, Fort Myers, Florida, United States
GSK Investigational Site, Orlando, Florida, United States
GSK Investigational Site, Baton Rouge, Louisiana, United States
GSK Investigational Site, Duluth, Minnesota, United States
GSK Investigational Site, Buffalo, New York, United States
GSK Investigational Site, Columbus, Ohio, United States
GSK Investigational Site, Tulsa, Oklahoma, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Sayre, Pennsylvania, United States
GSK Investigational Site, Corpus Christi, Texas, United States
GSK Investigational Site, Newport News, Virginia, United States
GSK Investigational Site, Seattle, Washington, United States
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR