Publication details

Phase I Trial in Oncology – Theory and Practice

Authors

DEMLOVÁ Regina OBERMANNOVÁ Radka VALÍK Dalibor VYZULA Rostislav

Year of publication 2012
Type Article in Periodical
Magazine / Source Klinická onkologie
MU Faculty or unit

Faculty of Medicine

Citation
Field Oncology and hematology
Keywords phase I trial; phase I unit; rule-based design; model based design; targeted therapy
Description 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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