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Clinical Trial Summary

The objective of the phase I part of the study is to determine the maximum tolerated dose and dose limiting toxicities of the combination of RAD001 and sorafenib in patients with untreated metastatic kidney cancer.


Clinical Trial Description

Phase I of the study will be an open-label dose escalation study to determine the MTD of the combination of sorafenib and RAD001. There will be a 7-day sorafenib run-in period prior to starting of RAD001 during cycle 1 to determine the pharmacokinetic effect of adding RAD001 on sorafenib drug levels. Starting doses will be set at RAD001 2.5 mg PO QD and sorafenib 400mg PO BID, continuously. Cycle length will be 4 weeks. Between 3 and 18 patients will be treated in the phase I portion of this study. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00384969
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 1
Start date October 2006
Completion date March 2014

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