Abstract
The primary goal of a cancer Phase I clinical trial is to determine the dose of a new drug or combination of drugs for subsequent use in Phase II trials to evaluate its efficacy. The dose sought is typically referred to as the maximally tolerated dose (MTD) and its definition depends on the treatment under investigation, the severity and reversibility of its side effects, and on clinical attributes of the target patient population. Since it is generally assumed that toxicity is a prerequisite for optimal antitumor activity (see Wooley and Schein, 1979), the MTD of a cytotoxic agent typically corresponds to the highest dose associated with a tolerable level of toxicity. More precisely, the MTD γ is defined as the dose expected to produce some degree of medically unacceptable, dose limiting toxicity (DLT) in a specified proportion θ of patients (see Gatsonis and Greenhouse, 1992). Hence, we have
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Tighiouart, M., Rogatko, A. (2006). Dose Finding in Oncology—Parametric 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_5
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DOI: https://doi.org/10.1007/0-387-33706-7_5
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