Safety and Toxicity Study of Sorafenib in Patients With Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00854620|
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : January 14, 2015
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell Kidney Disease Kidney Cancer||Drug: Sorafenib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma at Stanford University|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||January 2011|
Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)
- Time-to-progression (TTP) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854620
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Sandy Srinivas||Stanford University|