Dose Escalation Methods in Phase I Cancer Clinical Trials
University Health Network · University of Toronto · +2 more institutions
Abstract
Phase I clinical trials are an essential step in the development of anticancer drugs. The main goal of these studies is to establish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid accrual. Here we review dose escalation methods for phase I trials, including the rule-based and model-based dose escalation methods that have been developed to evaluate new anticancer agents. Toxicity has traditionally been the primary endpoint for phase I trials involving cytotoxic agents. However, with the emergence of…
Citation impact
- FWCI
- 22.42
- Percentile
- 100%
- References
- 93
Authors
3- CLChristophe Le TourneauCorresponding
University Health Network, University of Toronto, Princess Margaret Cancer Centre
- JJJ. Jack Lee
University Health Network, The University of Texas MD Anderson Cancer Center, University of Toronto, Princess Margaret Cancer Centre
- LLLillian L. Siu
The University of Texas MD Anderson Cancer Center, University of Toronto
Topics & keywords
- Clinical trial
- Medicine
- Clinical endpoint
- Maximum tolerated dose
- Phases of clinical research
- Drug
- Surrogate endpoint
- Pharmacology
- Good health and well-being