This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer
A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects with International Federation of Gynecology (FIGO) Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
Progression-free Survival (PFS) in Interim Analysis
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.
Time frame: From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)
Progression-free Survival (PFS) in Final Analysis
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Overall Survival
Overall survival is defined as the time from randomization until death due to any cause.
Time frame: From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)
Clinical Benefit Response
Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments.
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GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Orange, California, United States
GSK Investigational Site
Stanford, California, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
...and 53 more locations
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Response
Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Time to Response
For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Duration of Response
For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib
Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data.
Time frame: From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)