A study on phase I anti-cancer drug clinical trial using adaptive design

초록

The original traditional method for dose escalation has been criticized because it often tends to allocate slow dose escalation, includes too many patients at suboptimal dose levels and gives a poor estimate of the Maximum(MTD). The Pharmacologically Guided Dose Escalation (PGDE) method is effective because of developing many tools for PK analysis. PK analysis generally used in preclinical trials as well as Phase I clinical trials. However, the PGDE method consider a linear relationship between under the curve(AUC) and dose. We suggest new dose-escalation method using AUC of pharmacokinetics. This method can be used not only linear relationship but also non-linear relationship between AUC and dose. This method is efficient in Phase I clinical trials, especially for anticancer drug development.