drugset / Trial / NCT01616186
Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 5 mg | — |
| Subject | Sorafenib | Small molecule | 400 mg | — |
| Comparator | Sunitinib | Small molecule | 50 mg | — |