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. 2011 Jul 19;105(5):628–639. doi: 10.1038/bjc.2011.240

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Copyright © 2011 Cancer Research UK

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Typical phase 0/window of opportunity clinical trial design. Patients are randomised between the investigational medicinal product (IMP) and an inactive placebo for a variable time period (depending on the clinical situation governing management of the primary tumour). These studies have the potential to provide toxicity, response and biomarker (tissue and radiological) end points.