Protocol
11-178
Full Title
A Phase II, Open-Label, Randomized Study of GDC-0980 Versus Everolimus in Patients with Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy
Purpose
Therapies that target vascular endothelial growth factor (VEGF) are a part of standard therapy for metastatic renal cell carcinoma (RCC), but in many patients the cancer returns despite this treatment. Everolimus is another form of treatment for RCC. It works by targeting a protein involved in cancer growth called mTOR.
In this study, researchers are comparing an investigational drug called GDC-0980 to everolimus in patients with metastatic RCC that has continued to grow despite anti-VEGF therapy. GDC-0980 has been shown to inhibit mTOR more broadly than everolimus, as well as an enzyme involved in kidney cancer growth called PI3K.
Patients will be randomly assigned to receive either GDC-0980 or everolimus.
Investigator
Motzer, Robert, MD
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic renal cell carcinoma that has continued to grow during or within six months of stopping anti-VEGF therapy (such as sunitinib, sorafenib, pazopanib, bevacizumab, axitinib, or tivozanib).
- At least 2 weeks must have passed since completion of prior therapies (4 weeks since any major surgery) and entry into the study.
- Patients must be at least 18 years of age.
For more information about this study and to inquire about eligibility, please contact Dr. Robert Motzer at 646-422-4312.
Disease(s)
Kidney (Renal Cell) Cancer
Renal Cancer
