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Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents

Part of the SpringerBriefs in Statistics Book Series

DOI: 10.1007/978-4-431-55573-5

ISBN: 978-4-431-55572-8

Publisher: Springer Japan - Springer Journals

Jan 31, 2018

Available

Dose Finding in Phase I Cancer Trials

Hirakawa, Akihiro; Sato, Hiroyuki; Daimon, Takashi; Matsui, Shigeyuki

Pages: 1 –7

[The objective of phase I cancer trials is to determine the optimal dose of an agent or a combination of agents that can serve as a recommended phase 2 dose (RP2D). The conventionally defined RP2D of a cytotoxic agent corresponds to the maximum tolerated dose (MTD), defined as the highest dose...
Available

Dose Finding for a Combination of Two Agents

Hirakawa, Akihiro; Sato, Hiroyuki; Daimon, Takashi; Matsui, Shigeyuki

Pages: 9 –40

[Two-agent combination trials—involving a dose combination of two already marketed drugs or a single new investigational drug to be used in combination with an approved drug—have rapidly increased in number. The concurrent development of two new agents intended for use in combination to treat a...
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Dose Finding for Joint Assessment of Both Efficacy and Toxicity

Hirakawa, Akihiro; Sato, Hiroyuki; Daimon, Takashi; Matsui, Shigeyuki

Pages: 41 –58

[Traditionally, phase I trials are designed to determine the MTD of a new agent based solely on toxicity, regardless of the efficacy. The determination of an optimal dose based on the joint assessment of toxicity and efficacy of the drug in phase I dose-finding trials may be reasonable in some...
Available

Dose Finding for Molecularly Targeted Agents (MTAs)

Hirakawa, Akihiro; Sato, Hiroyuki; Daimon, Takashi; Matsui, Shigeyuki

Pages: 59 –80

[In the last 20 years, breakthroughs in the understanding of cancer cell biology resulted in the development of MTAs that are targeted to the unique genetics of each tumor and each patient. MTAs modulate specific aberrant pathways in cancer cells while sparing normal tissues, so that some MTAs do...
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Advanced Topics on Dose-Finding Designs

Hirakawa, Akihiro; Sato, Hiroyuki; Daimon, Takashi; Matsui, Shigeyuki

Pages: 81 –89

[Recently, many types of dose-finding methods were proposed to address the issues that we often encounter in practice. For instance, a seamless phase I/II trial that combines phase I and phase II trials has some advantages: the data on both toxicity and efficacy can be used more efficiently for...

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