A4061032 - Axitinib As Second Line Therapy for Mets Renal Cell Cancer
Research type
Research Study
Full title
Axitinib (AG-013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial.
IRAS ID
1
Sponsor organisation
Pfizer Ltd
Eudract number
2008-001451-21
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
AG 013736 (axitinib) is anoral, potent, and selective blocker of vascular endothelial growth factor(VEGF) receptors 1, 2, 3 and prevent the formation of new blood vessels thathelp cancers grow. To date, axitinib has been tested in over 1155 patients indifferent types of cancers, including kidney (renal cell) cancer, and has beenwell tolerated. This phase III, open-label (you will know which drug you arebeing treated with), two arm, randomized study will compare progression-freesurvival (no disease growth) in patients with kidney cancer treated withaxitinib (the investigational drug) or sorafenib (an approved drug) afterfailure of one a previous treatment. Other measurements will include overallsurvival (how long patients will live), the amount of tumour response (tumourreduction), safety, and quality of life. Participants in this study will berandomly assigned to one of two groups. One group of patients will receive theinvestigational drug axitinib at a starting dose of 5 mg twice a day with food.The other group will receive sorafenib at 400 mg twice a day without food.Patients in both treatment groups will continue to receive either axitinib orsorafenib as long as there is no disease growth or unacceptable side-effects.Several scans, test and exams will be provided throughout the study to closelymonitor patients. The study will be conducted in more than 20 countries.
REC name
West of Scotland REC 1
REC reference
08/S0703/113
Date of REC Opinion
7 Oct 2008
REC opinion
Further Information Favourable Opinion