NCT00854620

Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer

A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine time-to-progression (TTP) for an escalating dose schedule for subjects with progressive metastatic renal cell carcinoma treated with sorafenib

Detailed description

Sorafenib to be administered as 28-day cycles. Sorafenib dose escalation by cycle is: * Cycle 1: 400 mg BID * Cycle 2: 600 mg BID * Cycle 3+: 800 mg BID Within subject dose escalation and maximum dose is dependent on observed tolerability. Dose escalation only occurs after acceptable tolerability is demonstrated by subject.

Conditions

• Carcinoma, Renal Cell
• Kidney Disease
• Kidney Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-07-01
• Completion: 2011-01-01
• First posted: 2009-03-03
• Last updated: 2015-06-19
• Results posted: 2015-01-14

Locations

1 site across 1 country: United States