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Statistics in Clinical Cancer Research

Implementation of a model-based design in a phase 1b study of combined targeted agents

Nolan A. Wages, Craig A Portell, Michael E Williams, Mark R. Conaway and Gina R. Petroni
Nolan A. Wages
Public Health Sciences, University of Virginia
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  • For correspondence: nwages@virginia.edu
Craig A Portell
Division of Hematology / Oncology, University of Virginia
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Michael E Williams
Division of Hematology / Oncology, University of Virginia
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Mark R. Conaway
Public Health Sciences Admin, University of Virginia
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Gina R. Petroni
Public Health Sciences, University of Virginia
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DOI: 10.1158/1078-0432.CCR-17-1069
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Abstract

In recent years, investigators have recognized the rigidity of single agent, safety only, traditional designs, rendering them ineffective for conducting contemporary early-phase clinical trials, such as those involving combinations and /or biological agents.  Novel approaches are required to address these research questions, such as those posed in trials involving targeted therapies. We describe the implementation of a model-based design for identifying an optimal treatment combination, defined by low toxicity and high efficacy, in an early-phase trial evaluating a combination of two oral targeted inhibitors in relapsed / refractory mantle cell lymphoma.   <p>Operating characteristics demonstrate the ability of the method to effectively recommend optimal combinations in a high percentage of trials with reasonable sample sizes. The proposed design is a practical, early-phase, adaptive method for use with combined targeted therapies. This design can be applied more broadly to early-phase combination studies, as it was used in an ongoing study of a melanoma helper peptide vaccine plus novel adjuvant combinations.

  • Received April 12, 2017.
  • Revision received May 15, 2017.
  • Accepted July 13, 2017.
  • Copyright ©2017, American Association for Cancer Research.
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Published OnlineFirst July 21, 2017
doi: 10.1158/1078-0432.CCR-17-1069

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Implementation of a model-based design in a phase 1b study of combined targeted agents
Nolan A. Wages, Craig A Portell, Michael E Williams, Mark R. Conaway and Gina R. Petroni
Clin Cancer Res July 21 2017 DOI: 10.1158/1078-0432.CCR-17-1069

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Implementation of a model-based design in a phase 1b study of combined targeted agents
Nolan A. Wages, Craig A Portell, Michael E Williams, Mark R. Conaway and Gina R. Petroni
Clin Cancer Res July 21 2017 DOI: 10.1158/1078-0432.CCR-17-1069
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Clinical Cancer Research
eISSN: 1557-3265
ISSN: 1078-0432

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