Logistic retainment interval dose exploration design for Phase I clinical trials of cytotoxic agents.

ABSTRACT: Phase I studies of a cytotoxic agent often aim to identify the dose that provides an investigator specified target dose-limiting toxicity (DLT) probability. In practice, an initial cohort receives a dose with a putative low DLT probability, and subsequent dosing follows by consecutively deciding whether to retain the current dose, escalate to the adjacent higher dose, or de-escalate to the adjacent lower dose. This article proposes a Phase I design derived using a Bayesian decision-theoretic approach to this sequential decision-making process. The design consecutively chooses the action that minimizes posterior expected loss where the loss reflects the distance on the log-odds scale between the target and the DLT probability of the dose that would be given to the next cohort under the corr

SUBMITTER: Murray TA 

PROVIDER: S-EPMC8575315 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature