1 - 6 of 6 Chapters
[The primary objective of early-phase (phase I, or phase I/II) clinical trials of a given anticancer agent is to determine its optimal dose (OD) to be administered to a cancer patient, so as to obtain the highest efficacy while maintaining admissible toxicity. Thus, in oncology, early-phase...
[The primary objective of a phase I trial for an anticancer agent is to determine the maximum tolerated dose (MTD), which is defined as the dose having a toxicity (in particular, the dose-limiting toxicity) probability closest to the prespecified target toxicity probability level. Thus,...
[Phase I trial designs in oncology aim to determine the maximum tolerated doses for agents of interest. Traditionally, dose-finding designs for phase I trials can be classified as rule-/algorithm- or model-based designs. In Chap. 2, we focused on rule-based designs; in the present chapter, we...
[Phase I trials in oncology are designed to determine the maximum tolerated doses of agents of interest. The designs can traditionally be classified as rule-/algorithm- or model-based designs. A new design class, known as model-assisted designs, has been developed. In model-assisted designs, the...
[The primary objective of a phase I trial is conventionally to determine the maximum tolerated dose (MTD) of a new agent, on the premise that its toxicity and efficacy monotonically increase with increasing dose. This is because the MTD is expected to produce maximal efficacy under admissible...
[Cancer immunotherapy is a broad category of anticancer therapies that induce, enhance, or suppress the immune system of a patient to help beat cancer. This therapy can also be regarded as a type of biological therapy that uses substances made from living organisms to treat cancer, because it...
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