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Sponsors and Collaborators: |
Mahidol University Bayer |
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Information provided by: | Mahidol University |
ClinicalTrials.gov Identifier: | NCT00478114 |
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.
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Drug: sorafenib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Non-Comparative, Treatment Protocol for the Use of BAY 43-9006 (Sorafenib) in Patients With Advanced Renal Cell Carcinoma |
Estimated Enrollment: | 15 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | August 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
1 sorafenib
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Drug: sorafenib |
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men must use adequate birth control for at least 3 months after the last administration of sorafenib. Should a woman become pregnant while participating or while the partner of a patient is participating in the study, they should inform their treating physician immediately.
Exclusion Criteria:
Excluded therapies or medications, previous and concomitant:
Any investigational therapy while on this protocol or within 30 days prior to their first dose of sorafenib.
Contact: Vichien Srimuninnimit, Assist. Prof. | 662-419-7000 ext 4488 | sivsm@mahidol.ac.th |
Thailand, Bangkok | |
Siriraj Hospital, Department of Medicine | Recruiting |
Bangkoknoi, Bangkok, Thailand, 10700 | |
Contact: Vichien Srimuninnimit, Assist. Prof. 662-419-7000 ext 4488-9 sivsm@mahidol.ac.th | |
Principal Investigator: Vichien Srimuninnimit, Assist. Prof. |
Principal Investigator: | Vichien Srimuninnimit, Assist. Prof. | Siriraj Hospital, Bangkok, Thailand |
Study ID Numbers: | 12750 |
Study First Received: | May 23, 2007 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00478114 History of Changes |
Health Authority: | Thailand: Food and Drug Administration |
Renal Cell Carcinoma Sorafenib |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |