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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00854620
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase Phase 2
Start date December 2007
Completion date January 2011

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