SONATINA phase II - nelfinavir drug trial
Dr Sharma lead the SONATINA phase II randomised trial which investigated the safety and the activity of the radiosensitising drug, nelfinavir, administered before and during radiotherapy in patients with rectal carcinoma. Nelfinavir is a radiosensitiser which has shown to increase tumour blood flow in preclinical models.
The Oxford ECMC team conducted a pilot study of nelfinavir before and during hypofractionated pelvic radiotherapy (RT) in patients with rectal cancer to evaluate safety, changes in tumour perfusion and tissue biomarkers of radiosensitisation.
In addition to assessing the safety of this novel treatment combination the study also aimed to test the feasibility of a new biomarker measured in tumour tissue: Tumour Cell Density (TCD). The 10 patients recruited in this trial underwent serial scans to look at blood flow (using perfusion computed tomography and dynamic contrast enhanced magnetic resonance imaging) during treatment with nelfinavir and radiotherapy.
The SONATINA trial was the first one to show that nelfinavir-RT may be associated with increased blood flow to cancer and the tissue biomarker TCD may be a valuable tool in assessing potential radiosensitising drugs. Results were presented at the 2014 NCRI conference.