An Open Label, Single Arm Trial to Evaluate Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of First Line Therapy With Sunitinib or Pazopanib
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of patients progression-free after 6 months of treatment
Primary endpoint is proportion of patients progression-free by month 6 after starting everolimus treatment. A 'responder' will be defined as a subject without progression by month 6 whereas a 'non-responder' will be defined as a subject with progressive disease by month 6. The primary variable will be derived from radiologic tumor assessments according to RECIST 1.1.
United States: Food and Drug Administration