Toxicity Adaptive Lists Design: A Practical Design for Phase I Drug Combination Trials in Oncology.

ABSTRACT:

Purpose

We introduce a novel algorithmic approach to design phase I trials for oncology drug combinations.

Methods

Our proposed Toxicity Adaptive Lists Design (TALE) is straightforward to implement, requiring the prespecification of a small number of parameters that define rules governing dose escalation, de-escalation, or reassessment of previously explored dose levels. These rules effectively regulate dose exploration and control the number of toxicities. A key feature of TALE is the possibility of simultaneous assignment of multiple-dose combinations that are deemed safe by previously accrued data.

Results

A numerical study shows that TALE shares comparable operative characteristics, in terms of identification of the maximum tolerated dose (MTD), to alternative app

SUBMITTER: Russo M 

PROVIDER: S-EPMC11548939 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature