Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Cancer (RCC) Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 903
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Detailed description:
Overall Survival (OS), Patient-reported outcome (PRO)

Arms:
arm 1: Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted. arm 2: Placebo tablets matching in appearance were to be orally administered twice a day.

Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Multi Kinase Inhibitor intervention 2: Placebo

Protocol document: