Abstract
Phase I trials in oncology are conducted to obtain information on dose–toxicity relationship. Preclinical studies in animals define a dose with approximately 10% mortality (the murine LD10). One-tenth or two-tenths of the murine equivalent of LD10, expressed in milligrams per meters squared, is usually used as a starting dose in a Phase I trial. It is standard to choose a set of doses according to the modified Fibonacci sequence in which higher escalation steps have decreasing relative increments (100, 65, 50, 40, and 30% thereafter). Toxicity in oncology trials is graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (available online from the Cancer Therapy Evaluation Program website http://ctep.cancer.gov).
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Keywords
- Maximally Tolerate Dose
- Toxicity Rate
- National Cancer Institute Common Terminology
- Lower Dose Level
- Cancer Institute Common Terminology Criterion
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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Ivanova, A. (2006). Dose-Finding in Oncology—Nonparametric Methods. In: Ting, N. (eds) Dose Finding in Drug Development. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/0-387-33706-7_4
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DOI: https://doi.org/10.1007/0-387-33706-7_4
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