Phase 3 Study-Tivozanib in Patients with Advanced Renal Cell Carcinoma

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

• IRAS ID

  31051

• Contact name

  Timothy Eisen

• Sponsor organisation

  AVEO Pharmaceuticals, Inc.

• Eudract number

  2009-013219-37

• ISRCTN Number

  N/A

• Research summary

  A PHASE 3 RANDOMISED, OPEN-LABEL STUDY IN SUBJECTS WITH ADVANCED KIDNEY CANCER TO COMPARE TIVOZANIB (AV-951) TO SORAFENIB This study is being conducted to compare Tivozanib (study drug) with Sorafenib (comparator drug) to see if it can slow the growth of, or shrink kidney cancer (also know as renal cell carcinoma or RCC). In the UK, RCC is the tenth most common cause of cancer death in men and the thirteenth in women and 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. 17 countries worldwide are participating in this study including the USA, India, France, Italy and Germany. Approximately 500 patients with advanced RCC are planned to participate in this study that is estimated to last approximately 26 months. In the UK, the study will be conducted by specialist oncologists at NHS hospitals in England at the Oncology Units. This is an open-label, randomised study. Participants will be randomised to either the study or the comparator drug group. Treatment with the study drug will be given orally, daily for 3 weeks followed by 1 week off (1 cycle = 3 weeks on 1 week off). Treatment with the comparator drug will be given orally, twice daily and continuously. If the participant's cancer is not getting worse or there are no severe side effects, the treatment can continue for up to 2 years from the first dose. After 2 years, if the participants benefit from the study or comparator drug, may continue to receive therapy in a separate long-term study. Computed tomography (CT) scans, or magnetic resonance imaging (MRI), will be used to locate and monitor the cancer.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/50

• Date of REC Opinion

  4 Feb 2010

• REC opinion

  Further Information Favourable Opinion