Phase II study of axitinib in patients with metastatic renal cell cancer unsuitable for nephrectomy.
Disease site: Kidney cancer, urological cancers
Treatment modality: Systemic therapy
Status: In follow-up
A-PREDICT is a phase II, multicentre, open label, single arm trial investigating the efficacy of the oral vascular endothelial growth factor receptor inhibitor axitinib in the treatment of patients with metastatic renal cell carcinoma unsuitable for nephrectomy.
99 patients will be recruited from approximately 20 UK sites over 4 years. All patients will receive axitinib and will be asked to donate tissue, blood and urine samples in order to identify markers predictive of treatment response. Participants will continue to take axitinib for as long as they are deriving benefit and will be followed up for life.
Chief Investigator: Dr James Larkin, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
Sponsors: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Funding: Pfizer Inc. and Cancer Research UK (CRUKE/11/061)
Further information including recruitment progress is available from the following link:
UK Clinical Trials Gateway
Patient friendly information is available from the following link:
Publications and presentations
Stewart G, Lewis R, Fisher R, Morden J, Boleti E, Chowdhury S, Eisen T, Highley M, Vasudev N, Michael A, Pickering L, Stares M, Nicol D, Snowdon C, Bliss J, Swanton C, Larkin J. A-PREDICT: a phase II muticentre study of axitinib in patients with metastatic renal cell cancer unsuitable for nephrectomy (CRUK/11/061). Presented at: 10th National Cancer Research Institute Cancer Conference; 2014 Nov 2-5; Liverpool, UK.
Stewart G, Harrison D, Swanton C, Lewis R, Bliss J, Larkin J, Nicol D; on behalf of the A-PREDICT Trial Management Group. Multidisciplinary urological engagement in translational renal cancer research. BJU Int. 2014: 114(4): 474-475.
Fisher R, Rowan A, Stares M, Webster-Smith M, Lewis R, Kilburn L, Nicol D, Stewart G, Michael A, Vasudev N, Hazell S, Turaljic S, Pickering L, Gore M, Snowdon C, Bliss J, Swanton C, Larkin J; on behalf of the A-PREDICT Trial Management Group. A-PREDICT: a phase II study of axitinib in patients with metastatic renal cell cancer unsuitable for nephrectomy (CRUKE/11/061). Proceeds of ASCO 2014: abstract number TPS4597.