Phase 3 Study-Tivozanib in Advanced RCC Patients-Extension Protocol

• Research type

  Research Study

• Full title

  An Extension Treatment Protocol for Subjects who have Participated in a Phase 3 Study of Tivozanib vs. Sorafenib in Renal Cell Carcinoma (Protocol AV-951-09-301)

• IRAS ID

  35592

• Contact name

  Timothy Eisen

• Sponsor organisation

  AVEO Pharmaceuticals, Inc.

• Eudract number

  2009-015987-32

• ISRCTN Number

  N/A

• Research summary

  AN EXTENSION TREATMENT PROTOCOL FOR SUBJECTS WHO HAVE PARTICIPATED IN A PHASE 3 STUDY OF TIVOZANIB VS. SORAFENIB IN RENAL CELL CARCINOMA The main purpose of this study is to allow continued access to tivozanib (study drug) or sorafenib (Nexavar ©) (comparator drug) for patients with advanced kidney cancer (renal cell cancer - RCC) who participated in a previous phase 3 study, and to assess long-term safety in patients who continue treatment with the study drug. In the UK, RCC is the tenth most common cause of cancer death in men and the thirteenth in women, and this cancer is highly resistant to chemotherapy. Both the study drug and the comparator treatment are called anti-angiogenesis medicines. They fight the cancer by cutting off the tumour??s blood supply, so that it does not grow. This category of drugs has demonstrated significant anti-tumour activity, thus there is a need for further research. Participants who failed sorafenib on the parent protocol will be offered tivozanib. Those who were randomised to tivozanib, and demonstrated clinical benefit and acceptable tolerability will be offered long-term access to tivozanib. Participants who were randomised to sorafenib, and demonstrated clinical benefit and acceptable tolerability will be offered long-term access to sorafenib. Participants who continue receiving sorafenib on this protocol and progress will be allowed to cross-over to tivozanib. 17 countries worldwide are participating in this study including the USA, India, France, Italy and Germany. Up to 500 patients with advanced RCC could participate in this study that is expected to continue until the study drug becomes commercially available. In the UK, the study will be conducted by specialist oncologists at NHS hospitals in England at the Oncology Units. Computed tomography (CT) scans, or magnetic resonance imaging (MRI), blood and urine tests will be used to monitor the safety of the participants.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/51

• Date of REC Opinion

  11 Mar 2010

• REC opinion

  Further Information Favourable Opinion