A Study to Evaluate Efficacy and Safety of Pazopanib Monotherapy in Asian Women Who Have Not Progressed After First-line Chemotherapy for Advanced Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma - An Extension Study to VEG110655
This study is an extension study to the VEG110655 study. The parent study, VEG110655, was
designed to evaluate whether pazopanib 800 mg daily for 52 weeks will prolong progression
free survival (PFS) in women diagnosed with ovarian, fallopian tube or primary peritoneal
cancer. These women will have obtained stable disease, a complete remission, or a partial
remission after debulking surgery and at least five cycles of chemotherapy
(taxane/platinum). This extension study will evaluate safety and efficacy outcomes of
pazopanib monotherapy and placebo in an Asian population with the same indication as the
parent study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-free Survival (PFS)
PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
China: Food and Drug Administration
114012
NCT01227928
September 2010
February 2015
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