Evaluation of Safety in Biomarker Driven Multiple Agent Phase IB Trial

Motomi Mori (), Racky Daffé (), Byung S. Park () and Jeffrey Tyner ()
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Motomi Mori: Oregon Heatlh & Science University, Biostatistics, Knight Cancer Institute and School of Public Health
Racky Daffé: Oregon Heatlh & Science University, Biostatistics, Knight Cancer Institute and School of Public Health
Byung S. Park: Oregon Heatlh & Science University, Biostatistics, Knight Cancer Institute and School of Public Health
Jeffrey Tyner: Oregon Heatlh & Science University, Knight Cancer Institute and Department of Cell, Developmental and Cancer Biology

A chapter in Frontiers of Biostatistical Methods and Applications in Clinical Oncology, 2017, pp 53-64 from Springer

Abstract: Abstract Tyner and colleagues in the Center for Hematological Malignancies, Knight Cancer Institute, at the Oregon Health & Science University have recently developed a novel kinase-inhibitor assay and rapid mutationMutation screening to identify molecularly targeted drugsMolecularly targeted drug to which patient leukemic cells are sensitive. As a proof of concept and feasibility trial, they proposed a phase IB trial focusing on feasibility and safetySafety of an assay-based kinase-inhibitor treatment assignment in combination with the standard induction chemotherapy among newly diagnosed acute myeloid leukemia patients. Because each patient receives one of five kinase inhibitors in combination with standard chemotherapy, the sample size for each kinase inhibitor group is varied and limited. In addition, there is a different toxicity profile associated with each inhibitor, making safety assessment challenging. We will discuss a continuous Toxicity monitoring toxicity monitoring plan in biomarker driven, multiple agent feasibility and safety trials, and evaluate its operating characteristics in a simulationSimulation study.

Keywords: Phase I oncology trials; Early phase clinical trials; Continuous toxicity monitoring; Precision medicine; Safety evaluation; Multi-drug trials (search for similar items in EconPapers)
Date: 2017
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DOI: 10.1007/978-981-10-0126-0_5

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