Introduction

Axitinib is a potent oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) not previously tested in the UK in metastatic RCC patients with their primary tumour in situ. A-PREDICT aims to determine whether axitinib has activity in this population and explore biomarkers of activity and resistance

Methods

A-PREDICT is a phase II single group study (maximum n=99) of axitinib (starting dose 5mg BID) in patients with metastatic clear cell RCC unable to have immediate cytoreductive nephrectomy. Participants consented to provide biosamples (tumour, blood, urine) at baseline, on treatment and at progression. The primary endpoint is proportion of patients alive and free from disease progression (RECIST v1.1) at 6 months. Secondary endpoints include toxicity (CTCAE v4), progression free, overall survival and correlation of biomarkers with clinical endpoints.

Results

65 participants were recruited between 10/10/2012 and 23/12/2016. In December 2016 the Independent Data Monitoring and Steering Committee recommended that the trial close to recruitment as the pre-defined threshold level of activity had been reached. As of 19/12/2016 tumour samples were available for 92% participants at baseline, 87% on treatment and 13% at progression with equivalent return rates for blood and for urine samples._x000D_ Final data on response and toxicity will be available Q2 2017._x000D_

Conclusions

Recruitment to translational studies is challenging. Due to close cooperation of oncologists, urologists, radiologists and pathologists, A-PREDICT represents the largest UK translational therapeutic study of first line treatment using axitinib in metastatic RCC, presenting a unique opportunity to study mechanisms of sensitivity and resistance to axitinib. Importantly, axitinib met predefined activity thresholds.

Funding

Pfizer