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Clinical Trial DRUG XL184-308

Title
A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy
Principal Investigator
Timothy Kuzel
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG XL184-308
Purpose
The purpose of this study is to find out if cabozantinib is effective in treating kidney cancer compared to everolimus. This study will also examine how safe cabozantinib is and how well people with kidney cancer tolerate cabozantinib.
Overview
Cabozantinib is considered an investigational drug for use in kidney cancer because it has not been approved by the US Food and Drug Administration [FDA] for kidney cancer. Everolimus is approved by the FDA and other health authorities worldwide and is commercially available for the treatment of kidney cancer. Cabozantinib is US FDA approved for the treatment of progressive, metastatic medullary thyroid cancer.
Eligibility
Some of the eligibility criteria include:
  • Participants must have kidney cancer that includes a clear cell component.
  • Participants must have received at least one VEGFR-targeting tyrosine kinase inhibitor (e.g., sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
  • Participants must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants in this study will be assigned to get either cabozantinib or everolimus. Both cabozantinib and everolimus are taken by mouth once a day. Participants may receive study treatment as long as they do not have medically unacceptable side effects from cabozantinib or everolimus, and the study doctor judges the participant's condition to be appropriate for this study.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 30-Oct-14 01:54 PM

 

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