Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Overall Response by RECIST Criteria
The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the 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, Progressive disease (PD) = a \>=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.
Time frame: Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.
Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants
The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.
Time frame: Week 12
Duration of Response
Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.
Time frame: First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.
Progression-free Survival
Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a \>=20% increase in target lesions.
Time frame: From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)
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GSK Investigational Site
Duarte, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Orange, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Tucker, Georgia, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
...and 35 more locations