NCT00445042

Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2007-03-08
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States