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
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.
Inclusion Criteria:
Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell
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)
Prior cytokines therapy and prior vaccines in the adjuvant setting is permitted.
Patients must have had disease progression on or within 6 months of stopping the last therapy.
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).
Karnofsky performance status ā„ 70%
Patients must have the following laboratory values:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
La Jolla, California 92093-0658, United States
Los Angeles, California 90048, United States
Stanford, California 94304, United States
Minneapolis, Minnesota 55455, United States
Syracuse, New York 13210, United States
Troy, New York 12180, United States
Charleston, South Carolina 29425, United States
Dallas, Texas 75246, United States
Charlottesville, Virginia 22908-0334, United States
Buenos Aires, Buenos Aires C1050AAK, Argentina
Saint-Herblain CĆ©dex, 44805, France
Vandoeuvre-Les-Nancy Cede, 54511, France
Zrifin, 70300, Israel
Kitaadachi-gun, Saitama 362-0806, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Koto, Tokyo 135-8550, Japan
Minato-ku, Tokyo 105-8470, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Shinjuku-ku, Tokyo 162-8666, Japan
Las Palmas de Gran Canarias, Las Palmas de Gran Canaria 35016, Spain