A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor progression rate by RECIST criteria
restaging every 8 weeks
No
Robert J Amato, DO
Principal Investigator
The Methodist Hospital Research Institute
United States: Food and Drug Administration
Sorafenib-RCC-01
NCT00445042
November 2005
October 2008
Name | Location |
---|---|
The Methodist Hospital Research Institute | Houston, Texas 77030 |