A Study to Evaluate Efficacy and Safety of Pazopanib Versus Sunitinib for the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma - A Substudy to VEG108844
The study is designed to evaluate efficacy and safety of pazopanib versus sunitinib for the
treatment of Asian subjects with locally advanced and/or metastatic renal cell carcinoma
(RCC) enrolled from selected Far-East Asian countries. The primary objective is to evaluate
the primary endpoint progression free survival in the enrolled Asian subjects treated with
pazopanib versus those treated with sunitinib. The secondary objectives are to evaluate the
following secondary endpoints in each treatment arm: objective response rate, duration of
response, time to response, overall survival and safety. 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 (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
From randomization to the earliest date of disease progression or death (up to 39 months)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Taiwan: Department of Health
113078
NCT01147822
May 2010
December 2014
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