Study VEG108844, A Study of Pazopanib Versus Sunitinib in the Treatment of Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma
This study will evaluate the efficacy and safety of pazopanib compared to sunitinib in
subjects with advanced RCC who have received no prior systemic therapy for advanced or
metastatic RCC. Subjects will be randomized in a 1:1 ratio to receive either 800mg pazopanib
to be administered once daily orally continuous dosing or 50mg sunitinib to be administered
in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects
are permitted to receive supportive care throughout the study including transfusion of blood
and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents,
analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment will
continue until subjects experience disease progression, unacceptable toxicity, withdraw
consent, or death.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS)
PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.
From randomization until the earliest date of disease progression or death (up to Study Week 191)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United Kingdom: Medicines and Healthcare Products Regulatory Agency
108844
NCT00720941
August 2008
December 2014
Name | Location |
---|---|
GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
GSK Investigational Site | Bakersfield, California 93309 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | Indianapolis, Indiana 46260 |
GSK Investigational Site | Lexington, Kentucky 40536-0098 |
GSK Investigational Site | Springfield, Massachusetts 01107 |
GSK Investigational Site | Duluth, Minnesota 55805 |
GSK Investigational Site | St. Louis, Missouri 63141 |
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Savannah, Georgia 31405 |
GSK Investigational Site | Park Ridge, Illinois 60068 |
GSK Investigational Site | Bettendorf, Iowa 52722 |
GSK Investigational Site | Baltimore, Maryland 21201 |
GSK Investigational Site | Royal Oak, Michigan 48073 |
GSK Investigational Site | Oklahoma City, Oklahoma 73112 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Columbia, South Carolina 29210 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | Salem, Virginia 24153 |
GSK Investigational Site | New York, New York 10021 |
GSK Investigational Site | Aurora, Colorado 80012 |
GSK Investigational Site | Hartford, Connecticut 06106 |
GSK Investigational Site | Washington, District of Columbia 20307-5001 |
GSK Investigational Site | Hattiesburg, Mississippi 39401 |
GSK Investigational Site | Omaha, Nebraska 68131 |
GSK Investigational Site | Henderson, Nevada 89014 |
GSK Investigational Site | Edison, New Jersey 08837 |
GSK Investigational Site | Oregon City, Oregon 97045 |
GSK Investigational Site | Seattle, Washington 98133 |