Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
Carcinoma, Renal Cell
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University|
- Time-to-progression (TTP) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854620
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Sandy Srinivas||Stanford University|