Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
The purpose of this study is to determine the safety and toxicity levels of Dose Escalated Sorafenib in the treatment of patients with renal cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma|
- Tumor progression rate by RECIST criteria [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
- Time to progression and overall survival [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||October 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Intrapatient dose escalation study of sorafenib
The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the protocol, providing no dose limiting toxicity (Grade 3 or 4) is observed.
Other Name: Nexavar
Because tumors may have multiple mechanisms to induce angiogenesis, blockade with sorafenib may demonstrate efficacy. Doses of sorafenib (400 mg b.i.d.) as a single agent is with minimal toxicity, presents an opportunity to explore a more intensive drug administration. This study will allow individual patient titration (e,g,, intrapatient dose escalation) as per protocol.
This provides the basis for the dose escalation development of sorafenib. The study is designed to evaluate the ability for patients to dose escalate. Secondary endpoints include; response, time to progression, and overall survival in patients with MRCC. Tissue correlation to evaluate the impact of expression of receptor on clinical outcome will be retrospectively performed. Laboratory correlation of plasma VEGF levels will be correlated and evaluated to clinical outcome.
|United States, Texas|
|The Methodist Hospital Research Institute|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Amato, DO||The Methodist Hospital Research Institute|