Efficacy and Safety of Sorafenib in Advanced Renal Cell Carcinoma (RCC)
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|ClinicalTrials.gov Identifier: NCT00478114|
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : August 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: sorafenib||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Non-comparative, Treatment Protocol for the Use of BAY 43-9006 (Sorafenib) in Patients With Advanced Renal Cell Carcinoma|
|Study Start Date :||May 2007|
|Primary Completion Date :||August 2009|
|Study Completion Date :||March 2010|
sorafenib in the patients with advanced Renal Cell Carcinoma
Other Name: nexavar
- To evaluate the efficacy (time to progression and progression free survival) of sorafenib in patients with advanced RCC [ Time Frame: two years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478114
|Siriraj Hospital, Department of Medicine|
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator:||Vichien Srimuninnimit, Ass.Prof.||Siriraj Hospital, Bangkok, Thailand|