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New Oral VEGF-TKI, Tivozanib, Demonstrates Robust Anti-tumor Activity and Excellent Safety in Advanced Kidney Cancer Patients – Global Phase 3 TIVO-1 Trial Actively Recruiting

04/29/2010

AVEO Pharmaceuticals has recently initiated enrollment in a Phase 3 clinical trial evaluating tivozanib – a new oral, once-daily, triple VEGF receptor inhibitor – in patients with advanced kidney cancer, with nearly 500 patients worldwide expected to participate. TIVO-1 is a randomized, controlled trial evaluating tivozanib compared to sorafenib (Nexavar®), an FDA and EMEA approved therapy for the treatment of advanced renal cell carcinoma (RCC). The primary endpoint of the trial is progression-free survival (PFS), while secondary endpoints include overall survival, objective response rate, duration of response and quality of life. As the lead study investigator, I am excited to be a part of this important study and pleased to report that trial enrollment at sites spanning the United States, Canada, Europe and Asia is well underway.

 

Results from a previously completed Phase 2 clinical study of tivozanib demonstrate characteristics of a highly differentiated therapy; patients with clear cell RCC who had undergone a prior nephrectomy achieved a  median PFS of 14.8 months, with minimal side-effects commonly associated with other VEGF therapies (such as diarrhea, fatigue, rash, mucositis, stomatitis and hand-foot syndrome).

 

Individuals with RCC of clear cell histology that have had a prior nephrectomy and that have not received prior VEGF-targeted therapy are eligible for TIVO-1. If you think that you or one of your loved ones may be eligible, please contact AVEO Pharmaceuticals’ clinical operations department at clinicaltrials@aveopharma.com for additional information about eligibility criteria and to locate a trial site near you.

NeonCRM by Neon One