Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478114
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2007-05-23
Brief Title:
Efficacy and Safety of Sorafenib in Advanced Renal Cell Carcinoma RCC
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
An Open-label Non-comparative Treatment Protocol for the Use of BAY 43-9006 Sorafenib in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 eg 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 andor 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
1 Progression of disease
2 The patient is unlikely to benefit from further treatment with sorafenib as judged by the Investigator
3 Intolerable toxicity of the drug
4 Withdrawal of consent for any reason
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
1 Progression of disease
2 The patient is unlikely to benefit from further treatment with sorafenib as judged by the Investigator
3 Intolerable toxicity of the drug
4 Withdrawal of consent for any reason
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None