Cancer

Title
The Study of an Investigational Medication in Patients With Renal (Kidney) Cancer that has Returned (Recurrent) or Spread (Metastatic) and has Already Been Treated as a Participant in a Clinical Trial With Sorafenib, Sunitinib or Placebo (Sugar Pill) after an Initial Surgery
Trial Number
204487062012
Number of Participants
105
Principal Investigator

Joseph Clark

M.D.
Hematology/Oncology
Professor
Eligibility

Participants must be 18 years of age or older, and the following: Have locally recurrent or metastatic renal cell carcinoma requiring systemic therapy following treatment with sorafenib, sunitinib or placebo on an adjuvant study; participants will be required to have primary or recurrence tumor samples containing clear cell variant RCC with less than 50 percent of any other histology (including, but not limited to, papillary or chromophobe or oncocytic); recurrence must occur at least three months or more following the end of exposure to the adjuvant intervention; participants must have received greater than or equal to three, six-week cycles (18 weeks of treatment) of prior adjuvant treatment with sorafenib, sunitinib or placebo in the adjuvant setting on a clinical trial, or recurrence after three months of treatment on an adjuvant placebo arm.

Purpose

The purpose of this study is to find out what effects, good and/or bad, axitinib has on you and your renal cancer that has come back or spread. Axitinib is a new drug being studied and has not been approved for use in renal cancer.

Enrollment

(708) 327-3221

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