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Phase I Trial in Oncology – Theory and Practice

Authors: Demlová Regina, Obermannová Radka, Valík Dalibor, Vyzula Rostislav

Klinicka onkologie Journal. 2012; 25(Supplement 2): 98-101. DOI: 10.14735/amko20122S98.

Phase I trials in oncology usually enrolling patients with advanced disease who have failed standard treatment options. The primary endpoint of these studies is to establish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. The guiding principle for dose escalation in phase I trials is to avoid unnecessary exposure of patients to sub-therapeutic doses of an agent. The mission of phase I clinical trials is to accelerate the development of new anticancer drugs with the purpose of improving quality of life and survival for patients with cancer.


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