Combining cytotoxic agents with continuous dose levels in seamless phase I-II clinical trials.

ABSTRACT: Phase I-II cancer clinical trial designs are intended to accelerate drug development. In cases where efficacy cannot be ascertained in a short period of time, it is common to divide the study in two stages: i) a first stage in which dose is escalated based only on toxicity data and we look for the maximum tolerated dose (MTD) set and ii) a second stage in which we search for the most efficacious dose within the MTD set. Current available approaches in the area of continuous dose levels involve fixing the MTD after stage I and discarding all collected stage I efficacy data. However, this methodology is clearly inefficient when there is a unique patient population present across stages. In this article, we propose a two-stage design for the combination of two cytotoxic agents assuming a sing

SUBMITTER: Jimenez JL 

PROVIDER: S-EPMC9918144 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature