Clinical Trial DRUG XL184-308
- 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
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG XL184-308
- 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.
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
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- A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
- Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
- Phase II Trial of Everolimus or Everolimus plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma (GU10-147)
last updated: 10-Oct-15 12:17 AM
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