Phase 2 Preference Study of Tivozanib Hydrochloride vs Sunitinib

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-Blind, Crossover Controlled Multi-Center Subject Preference Study of Tivozanib Hydrochloride versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma

• IRAS ID

  110891

• Contact name

  Tim Eisen

• Sponsor organisation

  AVEO PHARMACEUTICALS, INC.

• Eudract number

  2012-001730-33

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This study will compare treatment with tivozanib and sunitinib in kidney cancer that has spread to other parts of the body that cannot be cured or easily controlled. Tivozanib is an investigational drug that has not been approved for use in any country. Treatment with tivozanib has been shown to shrink kidney cancers and slow the growth of these tumours. Sunitinib is a standard treatment for patients with advanced renal cell cancer, and has been approved for use by the European Medicines Agency (EMEA). Patients will receive either tivozanib or sunitinib for 12 weeks and then switch to the other drug for 12 weeks. The purpose of this study is to assess how participants feel during treatment with each of the drugs by the use of five questionnaires which ask about how they feel and any disease-related symptoms they may have, and to see which drug they prefer at the end of the study.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0435

• Date of REC Opinion

  21 Dec 2012

• REC opinion

  Further Information Favourable Opinion