Locally Metastatic Malignant Neoplasm Clinical Trial
Official title:
A Randomized Non-Comparative Multicenter Phase II Study of Everolimus/Sorafenib or Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)
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.
In the phase I study of the combination of everolimus and sorafenib, clinical benefit was observed in patients with no prior systemic therapy. There was no evidence of pharmacokinetic interaction and acceptable toxicity at a dosage of sorafenib of 400 mg twice daily (BID) and everolimus 5 mg daily. Based on these data and the need for more effective front-line therapy for renal cell carcinoma, the plan is to investigate this regimen in patients who have not undergone prior therapy. A sunitinib arm is being included as a concurrent reference to help provide a guideline of an activity level and toxicity that would be meaningful to move forward to a phase III study. Therefore, this study is designed as a non-comparative investigation and patients will be randomized in a 2:1 ratio to everolimus/sorafenib or to sunitinib, respectively. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment