drugset / Trial / NCT01616186

Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)

NCT01616186

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase II trial that follows the completion of the phase I UCSF trial of everolimus and sorafenib for Renal Cell Carcinoma (RCC). This trial will be for patients who have not had treatment for RCC before. This trial will have 2/3 patients getting everolimus/sorafenib treatment and 1/3 getting sunitinib, an FDA approved RCC drug. All three drugs are approved for advanced RCC when used individually, the combination of everolimus and sorafenib for RCC is not approved by the FDA.

Timeline

Start
2012-07
Primary completion
2015-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 5 mg
Subject Sorafenib Small molecule 400 mg
Comparator Sunitinib Small molecule 50 mg