Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents
Le résumé fourni par la source
The main goal in phase I trials for traditional cytotoxic agents is to determine the maximal tolerated dose (MTD). The underlying premise is that both efficacy and toxicity increase monotonically with increasing dose levels. Only toxicity, not efficacy, is monitored during a traditional phase I trial. The standard 3 + 3 design accrues three to six patients at a time to a given dose level and then increases the dose level until dose-limiting toxicity (DLT) is observed. If two or more DLTs are observed in a group of six patients at that dose level, dose escalation ceases and the MTD has been exceeded. The highest dose where no more than one DLT in six subjects is observed is the MTD. Mori reviews more recent phase I trial designs with better statistical properties in Chapter 4 of this Handbook ( 11 ).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents
- Date Crossref
- 01/12/2025
- Éditeur
- Chapman and Hall/CRC
- Type
- book-chapter
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.