A Study to Compare the Effectiveness of Tivozanib Hydrochloride verses Sorafenib in Patients with Advanced Renal Cell Cancer

What we are studying

Renal cell cancer is a type of kidney cancer that starts in the lining of very small tubes in the kidney. Like other cancers, renal cell cancer begins small and grows larger over time. For the cancer growth, new blood vessels need to form to supply nutrients to the cancer cells. Drugs that target the development of blood vessels that feed the tumor have shown significant effect to suppress cancer activity. These drugs have become the standard of care for the treatment of patients with advanced renal cell cancer. Tivozanib is a drug that blocks the development of blood vessels that trigger the cancer cells to divide and grow. Tivozanib is being investigated in clinical studies. Results from the completed studies suggest that tivozanib is generally well tolerated. The purpose of this study is to compare the effectiveness of tivozanib in renal cell cancer compared to an approved drug “sorafenib” which works in a similar way to tivozanib. Tivozanib and sorafenib are both called “study medication”. This study will also see whether tivozanib is safe and tolerable for patients with advanced renal cell cancer.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • • You have not previously received treatment with sorafenib or tivozanib. • You have not already received more than 3 types of treatment for renal cell cancer. • You have no physical or mental condition that could interfere with your participation in the study. • You have no other types of active cancer. • You have recovered from a surgery performed within the 4 weeks before taking the first dose of your study medication. • You cannot be pregnant or breastfeeding. • You cannot currently be participating in any other clinical study.

What is involved

  • Physical examinations
  • Blood laboratory tests
  • Thyroid function tests
  • ECG
  • CT and/or MRI scans

Compensation

None

Contact Information

Study Coordinator
Patricia Smith, RN
Email
psmith@wakehealth.edu
Phone
336-713-4416

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.