[Phase I clinical trial design of anticancer agents--a Fibonacci and a modified Fibonacci sequence].
A Phase I clinical trial of an anticancer agent is the first evaluation in humans, and it is an important step in drug development. From the ethical point of view, the goal is to escalate to the maximum tolerated dose quickly, yet safely, to minimize the likelihood of treating patients at doses that are too low or high. It is expected that the contradictions between safety and efficacy in the Phase I clinical trials will be solved by developing methods. The modified Fibonacci sequence has been generally adopted for dose escalation, although it includes some problems. It is necessary to recognize that the method used for Phase I clinical trials for anticancer agents remains unsatisfactory, and that it is also necessary to develop more ethical and scientific methods.
Kusaba
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Dept. of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan.
Tamura
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T
D000818:Animals; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D004334:Drug Administration Schedule; D006801:Humans; D051379:Mice; D009369:Neoplasms / Q000188:drug therapy*; D012107:Research Design
D000970:Antineoplastic Agents