An open-label study of tivozanib versus sorafenib in renal cell cancer
Research type
Research Study
Full title
A Phase 3, Randomised, Controlled, Multi-Centre, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
IRAS ID
189564
Contact name
Michael Dudley
Contact email
Sponsor organisation
AVEO PHARMACEUTICALS, INC.
Eudract number
2015-003607-30
Duration of Study in the UK
3 years, 1 months, 15 days
Research summary
Approximately 208,500 new cases of kidney cancer are diagnosed in the world each year, of which 63,300 new cases are diagnosed the European Union (EU). Renal cell carcinoma (RCC) accounts for 80%-85% of all malignant kidney tumours.
For 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 tumour have shown significant effect to suppress cancer activity. These drugs have become the standard of care for the treatment of patients with advanced RCC.
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 and 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. This study will also see whether tivozanib is safe and tolerable for patients with advanced renal cell cancer.
Participants with advanced renal cell cancer will randomly assigned to receive either tivozanib or sorafenib. About half of the participants will receive tivozanib and about half of participants will receive sorafenib. This study is “open label”, which means that both the participant and the study doctor will know which drug the participant is receiving.
Cycles of treatment with tivozanib or sorafenib will be repeated every 4 weeks (28 days). The duration of participation is approximately 24 months.
It is anticipated that approximately 322 participants will be recruited worldwide from 160-190 sites, with 15 of participants coming from the UK
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0009
Date of REC Opinion
18 Mar 2016
REC opinion
Further Information Favourable Opinion