SAPROCAN: Saracatinib (AZD0530) and docetaxel in metastatic, castrate-refractory prostate cancer: a phase I/randomised phase II study by the UK NCRI Prostate Clinical Studies Group v1

Design:Phase I followed by a phase II randomised placebo controlled trial. Aims:To provide preliminary evidence regarding whether the addition of saracatinib (AZD0530) to first line docetaxel plus prednisolone will increase progression free survival in patients with metastatic, castrate refractory prostate cancer. Outcome Measures: Phase I: Safety and tolerability Phase II: Progression free survival Treatment: All patients will receive docetaxel by iv infusion once every 3 weeks for a maximum of 10 cycles with prednisolone 5mg bd po daily from the first day of docetaxel up to at least day 21 of the final dose. Phase I Patients in the phase I component of the study will commence once-daily saracatinib (AZD0530) on day 11 of the first cycle of docetaxel (dose as specified) po. They will continue until disease progression is confirmed. Phase II Patients in the phase II component of the study will be randomly assigned to receive either saracatinib (AZD0530) once daily by mouth at a dose to be defined in phase I or a matching placebo. This will be taken by mouth starting 7 days prior to the first dose of docetaxel and stopping when disease progression is confirmed. Duration of treatment Up to 10 cycles of docetaxel will be given. Prednisolone should be continued until 21 days after the last dose of docetaxel but may continue beyond this at the discretion of the investigator. Saracatinib should be continued until disease progression or withdrawal. The expected median duration of therapy is around 37 weeks and is unlikely to exceed 68 weeks. Duration of study participation Study participation will commence when the patient gives written informed consent and will continue until both disease progression and resolution of study drug toxicity have occurred. Survival information will continue to be collected after these events have occurred until the study is completed.