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Activity Number: 405 - Statistical Issues Specific to Therapeutic Areas
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #304815 Presentation
Title: Two New Dual-Agent Dose Escalation Methods
Author(s): Yue Yang* and Wentao Feng and Qianwen Tan and Lisa Brown
Companies: North Carolina State University and Seattle Genetics and Seattle Genetics and Seattle Genetics
Keywords: dual-agent trial; dose escalation; mTPI; PIPE

There is increasing interest in dual-agent dose finding trials, especially in oncology research. In recent years, various dual-agent dose escalation designs, including both model-based and rule-based trial designs, have been proposed. The performance of these methods depends on the pattern of the underlying toxicities. We developed two novel dual-agent dose escalation methods: Combo mTPI and mTPI+PIPE. Our proposed methods make escalation/de-escalation decisions according to the mTPI decision table and recommend dose level combinations for the next cohort according to pre-specified rules. The performance of our two proposed methods was compared with BLRM and PIPE in simulation studies under different dose-toxicity models. Overall, our methods demonstrated more stable performance across scenarios. Furthermore, the proposed methods offer an intuitive approach to dual-agent dose escalation that can be easily understood by clinicians with straightforward implementation.

Authors who are presenting talks have a * after their name.

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