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Activity Number:
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481
- Dose Finding, Dose Selection, and Early-Phase Trials
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Type:
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Contributed
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Date/Time:
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Wednesday, August 10, 2022 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #320715
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Title:
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Early Completion of Model-Assisted Designs for Dose-Finding Trials
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Author(s):
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Masahiro Kojima*
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Companies:
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Kyowa Kirin Co, Ltd.
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Keywords:
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phase I dose-finding trial;
Model-assisted design
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Abstract:
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We propose a novel early completion method for phase I dose-finding trials using model-assisted designs. The early completion is determined when a maximum tolerated dose (MTD) is estimated with sufficient accuracy. Early completion can reduce the average number of patients treated relative to the planned number, thereby allowing the trial to proceed to enrolling an expansion cohort for efficacy and enabling the trial to reach the next phase faster. To determine the early completion, we developed a dose-retainment probability. We evaluated early the completion for two actual trials. In addition, we performed a computer simulation to confirm an accuracy and the average number of patients treated. In the evaluation of the two actual trials, we confirmed that the trials completed early. In the simulation results, we confirmed that the percentages of correct MTD selection were maintained relative to the original model-assisted designs. The early completion percentages ranged from 50% to 90%, and the number of patients treated reduced from 20%-60% relative to the planned number of patients.
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Authors who are presenting talks have a * after their name.
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