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 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria
The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.
Baseline through End of Study (up to 2 years)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
109609
NCT00549328
February 2008
April 2009
Name | Location |
---|---|
GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | New Orleans, Louisiana 70112 |
GSK Investigational Site | Duluth, Minnesota 55805 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Oklahoma City, Oklahoma 73112 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Salem, Virginia 24153 |
GSK Investigational Site | New York, New York 10021 |