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 (XL184-308)
The purpose of the study is to find out if cabozantinib is effective in treating kidney cancer compared to everolimus. This study will also examine how safe cabozantinib is and how well people with kidney cancer tolerate cabozantinib. If you join this study, you may receive the investigational drug cabozantinib (XL184) or everolimus.
People with advanced form of renal cell carcinoma (kidney cancer) that has not responded or has progressed (gotten worse) after treatment with other drugs may join.
About 650 subjects (325 in each group) will take part in this study. About 8 will be enrolled at Johns Hopkins. The study compares two treatment arms after you complete all screening tests: Group 1: Oral cabozantinib (60 mg) once daily, and Group 2: Oral everolimus (10 mg) once daily. You have an equal chance of being assigned to either group. Both you and your study doctor will know what study drug you are taking. You will not be allowed to change from one study group to the other while on study. During treatment, you will have study visits every 2 weeks during the first 8 weeks, and then every 4 weeks until the end of study drug period. You will have tumor assessments by CT/MRI and bone scans every 8 weeks during the first 12 months of study drug, and then every 12 weeks. You will also be asked to complete questionnaires regarding your health status and quality of life every 4 weeks during the first 24 weeks, and then every 8 weeks. After you have stopped receiving the study drug you will return to the clinic after about 30 days for a follow up visit. After it is decided that you will no longer need to undergo study assessments, the study staff will also contact you by telephone about every 8 weeks after that to see how you are doing and if you have received another anticancer treatment.
09/19/2014 04:03 AM