Online Program

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Tuesday, September 24
Tue, Sep 24, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL25: Oncology Novel Phase I Dose-Escalation Design in the Real Trial Setting (300919)

*Wei Zhong, Pfizer Inc. 

Keywords: Oncology

Room Wilson A

For oncology phase I dose escalation trials, many novel designs have been proposed to improve the identification of the maximum tolerated dose (MTD). However in pharmaceutical industry, there are only a few popular designs implemented in real clinical trials (eg. BLRM, mTPI). The different setting of the escalation and stopping rules may also greatly impact the design performance even using the same type of design. Moreover, some trial investigators advocated the late cycle information synthesis into MTD determination in recent years. There are some gaps between the methodology establishment and the real trial implementation that needs our further investigation. Our session will address those issues during the real trial implementation. See below for the sample questions for discussion. 1. How can we choose the optimal design including the selection of stopping rule and escalation rule in different conditions? 2. How can we incorporate late cycle DLT/AE information into dose escalation decision making in practice? 3. What problems may arise in MTD determination for monotherapy and combination therapy dose escalation and how can we mitigate the risk?