A Phase I/II adaptive design for heterogeneous groups with application to a stereotactic body radiation therapy trial. (11th May 2015)

• Record Type: Journal Article
• Authors: Wages, Nolan A.; Read, Paul W.; Petroni, Gina R.
• Is Part Of: Pharmaceutical statistics. Volume 14:Number 4(2015:Jul./Aug.)
• Page Start: 302
• Page End: 310
• Publication Date: 2015-05-11
• Subjects: Pharmacy -- Statistical methods -- Periodicals; Pharmacy -- Statistics -- Periodicals; 615.10727
• DOI: 10.1002/pst.1686
• Languages: English
• ISSNs: 1539-1604

Abstract

<abstract abstract-type="main" id="pst1686-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <p id="pst1686-para-0001">Dose‐finding studies that aim to evaluate the safety of single agents are becoming less common, and advances in clinical research have complicated the paradigm of dose finding in oncology. A class of more complex problems, such as targeted agents, combination therapies and stratification of patients by clinical or genetic characteristics, has created the need to adapt early‐phase trial design to the specific type of drug being investigated and the corresponding endpoints. In this article, we describe the implementation of an adaptive design based on a continual reassessment method for heterogeneous groups, modified to coincide with the objectives of a Phase I/II trial of stereotactic body radiation therapy in patients with painful osseous metastatic disease. Operating characteristics of the Institutional Review Board approved design are demonstrated under various possible true scenarios via simulation studies. Copyright © 2015 John Wiley &amp; Sons, Ltd.</p> </abstract>