Abstract
e15055 Background: Single arm phase II studies provide limited information with respect to the efficacy of new treatments. A randomized phase II study using PFS as endpoint allows a more reliable PoC for further development of the new treatment in phase III. A PoC phase II design is proposed to establish the non-inferiority of a new treatment compared to a control treatment. Methods: A Bayesian PoC phase II design is proposed with the objective to have (1) a reasonably promising effect (treatment vs. control) estimate, and (2) good evidence that the treatment is better than a predefined non-inferiority margin. For (1) clinical input is required in order to implement an explicit rejection bound for the estimated effect, e.g. the maximum observed hazard ratio (HR) which could be still considered as similar to 1 (HR=1 means no treatment difference). The design is applied in the RECORD-3 (Renal cell cancer treatment with oral RAD001 given Daily) trial comparing the treatment sequence everolimus
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