Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00445042|
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: Sorafenib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||October 2008|
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
- Tumor progression rate by RECIST criteria [ Time Frame: restaging every 8 weeks ]
- Overall response rate [ Time Frame: restaging every 8 weeks ]
- Time to progression and overall survival [ Time Frame: restaging every 8 weeks ]
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): NCT00445042
|United States, Texas|
|Methodist Hospital - Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J Amato, DO||Baylor College of Medicine - Methodist Hospital|