Phase I Clinical Trials with Anticancer Agents
Although the term “phase I” is used to describe numerous trial designs, the overarching goal of a phase I study is to determine the optimal dose and/or schedule of a therapy for evaluation in the phase II setting. Phase I trials typically test different doses of an anticancer agent(s) in various neoplastic diseases, with safety evaluation as a main objective. These studies range from first-in-human trials of novel single agents to new combinations of FDA-approved therapies. Frequently, pharmacokinetic studies are incorporated in phase I clinical trials, in order to determine drug exposure and clearance. In addition, phase I studies may include biomarkers of drug effects such as functional imaging or direct measurement of drug effects on either tumor biopsies and/or normal tissue samples.
KeywordsDose Level Dose Escalation Oncology Trial Human Equivalent Dose Animal Dose
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