Protocol
10-084
Full Title
An Open-label, Multicenter Phase 1b/2 Study of E7080 Alone, and in Combination with Everolimus in Subjects with Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment (E7080-G000-205)
Purpose
The purpose of this study is to find the highest dose of an investigational drug called E7080 that can be given in combination with everolimus in patients with advanced or metastatic renal cell carcinoma (a serious form of kidney cancer) that persists despite prior treatment with a drug that targets the VEGF receptor. Both E7080 and everolimus are taken orally (by mouth).
E7080 is thought to work by stopping the formation of new blood vessels that help cancer cells grow and spread. Everolimus is already approved for treating renal cell carcinoma. It works by inhibiting a protein called mTOR, which is involved in tumor cell growth and the growth of blood vessels that help cancer cells grow and spread.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of advanced or metastatic renal cell carcinoma that persists despite one prior VEGF-targeted treatment (such as sunitinib, sorafenib, pazopanib, bevacizumab, axitinib, vatalanib, or AV951/ tivozanib).
- At least 3 weeks must have passed since completion of prior therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Ana M. Molina at 646-422-4313.
Disease(s)
Kidney Cancer
Locations
ClinicalTrials.gov
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