An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies
This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Sorafenib
- drug : Dovitinib
Phase: Phase 3
Ages Eligible For Study:
1. Age ? 18 years old 2. Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell 3. Patients must have received one and only one prior VEGF-targeted therapy and one and only one prior mTOR inhibitor therapy in the metastatic setting. One VEGF targeted therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and one prior mTOR inhibitor therapy (everolimus, or temsirolimus or ridaforolimus) 4. Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted. 5. Patients must have had disease progression on or within 6 months of stopping the last therapy. 6. Patients must have at least one measurable lesion at baseline (by RECIST Criteria Guidelines v1.1) assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI). 7. Karnofsky performance status ? 70% 8. Patients must have the following laboratory values: - Absolute Neutrophil Count (ANC) ? 1.5 x 109/L - Platelets ? 100 x 109/L - Hemoglobin (Hgb) > 9 g/dL - Serum total bilirubin: ? 1.5 x ULN - ALT and AST ? 3.0 x ULN (Patients with known liver metastases: AST and ALT ? 5.0 x ULN) - Serum creatinine ? 1.5 x ULN