Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

2014-08-27 03:39:45 | BioPortfolio


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.


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 Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Carcinoma, Renal Cell




The Methodist Hospital Research Institute
United States




The Methodist Hospital System

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:39:45-0400

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