A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.
Renal Cell Carcinoma
Drug: Cabozantinib (XL184)
Drug: Everolimus (Afinitor)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy|
- Progression-free survival (PFS) [ Time Frame: up to 17 months ] [ Designated as safety issue: No ]PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed for up to 17 months.
- Overall Survival (OS) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]OS is measured from the time of randomization until death due to any cause assessed up to 36 months.
- Objective Response Rate (ORR) [ Time Frame: up to 17 months ] [ Designated as safety issue: No ]ORR is the proportion of subjects, assessed up to 17 months, who have measurable disease at baseline and who have complete response (CR) or partial response (PR) at data cut off.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) administered as an oral single tablet once daily.
|Drug: Cabozantinib (XL184)|
Active Comparator: Everolimus (Afinitor)
Everolimus (Afinitor) administered as an oral single tablet once daily.
|Drug: Everolimus (Afinitor)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01865747
|Contact: Exelixis Clinical Trials||1-888- EXELIXIS (888-393-5494)||firstname.lastname@example.org|
|Contact: Backup or International||650-837-7400|
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