A Phase III Study of Cabozantinib versus Everolimus in Patients with Progressive Kidney Cancer

Protocol
13-124
Full 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 (XL184-308)
Phase
III
Purpose

Everolimus is a standard drug used to treat an aggressive form of kidney cancer called renal cell carcinoma. It works by inhibiting a molecule called mTOR, which helps cancer cells grow. However, in some patients the cancer continues to grow despite everolimus.

Cabozantinib (XL184) is a drug that blocks several proteins (called MET, RET, and vascular endothelial growth factor receptor 2) that help keep cancer cells alive. It is approved for treating thyroid cancer, but its use for renal cell carcinoma is considered investigational.

In this study, researchers are comparing the effectiveness of cabozantinib and everolimus in patients with renal cell carcinoma that has continued to grow despite receiving treatment that inhibited an enzyme called tyrosine kinase (“tyrosine kinase inhibitors”). They hope that cabozantinib is more effective than everolimus for treating progressive kidney cancer. Patients will be randomly assigned to receive everolimus or cabozantinib, but not both. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have renal cell carcinoma that has returned or continued to grow despite prior treatment with a tyrosine kinase inhibitor (such as sunitinib, sorafenib, axitinib, pazopanib, or tivozanib).
  • At least 2 weeks must have passed since the last dose of a tyrosine kinase inhibitor and entry into the study. Patients must have recovered from the serious side effects of prior therapies.
  • Patients may not have had previous treatment with everolimus or cabozantinib.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Robert Motzer at 646-422-4312.

Disease(s)
Kidney Cancer
Locations
Related Diseases

Cancer Clinical Trials: Personalizing for Each Patient

Join our experts for a discussion of clinical trials on November 18. Clinical trials can give patients access to new drugs and other treatments before they are widely available, but how do you know if a trial is right for you?

Learn more »