Phase I dose-escalation oncology trials with sequential multiple schedules.

ABSTRACT:

Background

Conventional methods for phase I dose-escalation trials in oncology are based on a single treatment schedule only. More recently, however, multiple schedules are more frequently investigated in the same trial.

Methods

Here, we consider sequential phase I trials, where the trial proceeds with a new schedule (e.g. daily or weekly dosing) once the dose escalation with another schedule has been completed. The aim is to utilize the information from both the completed and the ongoing schedules to inform decisions on the dose level for the next dose cohort. For this purpose, we adapted the time-to-event pharmacokinetics (TITE-PK) model, which were originally developed for simultaneous investigation of multiple schedules. TITE-PK integrates information from multiple sched

SUBMITTER: Gunhan BK 

PROVIDER: S-EPMC8045405 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature