4 papers
A seamless dose-optimization design for monotherapy and combination therapy
Kentaro Takeda, Masahiro Kojima
The emergence of molecular-targeted agents and immune-oncology therapies has fundamentally transformed oncology drug development, necessitating evolution beyond traditional dose-fi…
Hybrid Non-informative and Informative Prior Model-assisted Designs for Mid-trial Dose Insertion
Kana Yamada, Hisato Sunami, Kentaro Takeda +2
In oncology phase I trials, model-assisted designs have been increasingly adopted because they enable adaptive yet operationally simple dose adjustment based on accumulating safety…
BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity
Kai Chen, Yixuan Zhao, Kentaro Takeda +1
The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maxim…
ROMI: A Randomized Two-Stage Basket Trial Design to Optimize Doses for Multiple Indications
Shuqi Wang, Peter F. Thall, Kentaro Takeda +1
Optimizing doses for multiple indications is challenging. The pooled approach of finding a single optimal biological dose (OBD) for all indications ignores that dose-response or do…