gms | German Medical Science

Objective: The primary objective of this clinical study is to make Sorafenib (BAY43‑9006) available for patients with advanced renal cell carcinoma, who failed prior systemic therapy for advanced disease (i. e., require second line treatment). In addition, safety data and limited efficacy data will be collected for Sorafenib in this indication.

Patients and methods: Patients of at least 18 years of age with advanced RCC, who received at least one prior systemic therapy for advanced RCC, and who may benefit from treatment with Sorafenib, are eligible. Patients with brain metastases or with severe cardiac, hepatic, or renal impairment, are excluded. Patients must not receive concomitant systemic anti-cancer therapy other than bisphosphonates. Patients will be treated with 400 mg oral Sorafenib twice a day on a continuous basis as a single agent until progression of disease or intolerable toxicity of the drug. Doses of study drugs may be delayed or reduced in case of clinically significant toxicities that are related to the therapy. At maximum, a total of 1,500 patients will be enrolled into this clinical study.

Results: Incidence rates of Treatment-Emergent Adverse Events will be provided for all Serious Adverse Events, Drug Related Adverse Events, and Grade 3 and Grade 4 Adverse Events. Patient demographic data and baseline characteristics will be analysed by summary statistics for quantitative variables and frequency tables for qualitative variables. Efficacy data will be summarized by frequency tables based on the Investigator assessment of clinical and/or radiological findings. Time to progression (TTP) and progression-free survival time (PFS) will be analysed as well.