Efficacy and Safety of Sorafenib in Advanced Renal Cell Carcinoma (RCC)
This is the early access programme (EAP) of sorafenib in the indication of advanced renal cell carcinoma (RCC). The study is to evaluate the efficacy and safety of sorafenib in patients with advanced RCC.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Non-comparative, Treatment Protocol for the Use of BAY 43-9006 (Sorafenib) in Patients With Advanced Renal Cell Carcinoma|
- To evaluate the efficacy (time to progression and progression free survival) of sorafenib in patients with advanced RCC [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- To evaluate the safety (all drug-related adverse events, all adverse events NCI CTCAE 3.0 Grade 3 or higher) of sorafenib in patients with advanced RCC [ Time Frame: two years ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
sorafenib in the patients with advanced Renal Cell Carcinoma
Other Name: nexavar
Renal cell carcinoma (RCC) accounts for approximately 3 % of all cancers. RCC can be cured if diagnosed and treated when still localized to the kidney or immediate surrounding tissues. Since most of the RCC tumours are diagnosed when still localized, approximately 40 % of all patients survive 5 years. The median survival of Stage IV RCC after diagnosis is 8 to 12 months and the 5-year survival is less than 10 %. Surgery has been the primary therapy for RCC for more than a century. Until recently, metastatic disease has been refractory to any systemic therapy. Despite recent advances in immunotherapy (e.g. Interferon and Interleukin-2), the response rates remain low (15 %) and few patients experience durable remission. Surgical and radiation therapies for Stage IV disease are generally limited to palliation of symptoms. For the majority of patients, metastatic RCC is incurable and patients should be considered candidates for clinical trials when appropriate. In summary, the available therapies for advanced unresectable and/or metastatic RCC have limited clinical values, with response rates ranging from 6-20 % and little impact on the natural history of the disease. Furthermore, the toxicities associated with these agents can be severe, requiring careful patient selection, and this dramatically decreases the number of patients who may benefit from therapy. Advanced RCC remains incurable and the need for more effective therapies is high.
This is a non-randomized, open-label treatment protocol for patients with advanced RCC. Patients will be treated with 400 mg oral sorafenib twice a day on a continuous. Patients in this protocol may continue to be treated with sorafenib as a single agent until any of the following criteria for drug or protocol discontinuation is reached:
- Progression of disease.
- The patient is unlikely to benefit from further treatment with sorafenib as judged by the Investigator.
- Intolerable toxicity of the drug.
- Withdrawal of consent for any reason.
|Siriraj Hospital, Department of Medicine|
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator:||Vichien Srimuninnimit, Ass.Prof.||Siriraj Hospital, Bangkok, Thailand|