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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Pazopanib monotherapy
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Fort Myers, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
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.
Time frame: Baseline through End of Study (up to 2 years)
Number of Participants Who Had a Complete or Partial Response, or Stable Disease
Disease control was measured. Stable disease (SD) is defined as neither partial response (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) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.
Time frame: Baseline through End of Study (up to 2 years)
Progression-Free Survival
Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.
Time frame: Baseline through End of Study (up to 2 years)
Overall Survival
Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.
Time frame: Baseline through End of Study (up to 2 years)
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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
...and 3 more locations
Levels of Circulating Biomarkers in Plasma
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Time frame: Baseline through End of Study (up to 2 years)
Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers
Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.
Time frame: Baseline through End of Study (up to 2 years)