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Activity Number: 584 - Innovations and Breakthroughs in Oncology Dose Finding Designs for Time-to-Event Monitoring and Trial Acceleration in the New Age of Immunotherapy and Cell Therapy
Type: Topic Contributed
Date/Time: Thursday, August 6, 2020 : 3:00 PM to 4:50 PM
Sponsor: Section on Risk Analysis
Abstract #309651
Title: TITE-BOIN-ET: Time-to-Event Bayesian Optimal Interval Design to Accelerate Dose-Finding Based on Both Efficacy and Toxicity Outcomes
Author(s): Kentaro Takeda*
Companies: Astellas Pharma Global Development, Inc.
Keywords: Bayesian adaptive dose-finding design; efficacy toxicity; late-onset outcomes; model-assisted design; phase I-II clinical trial design

The primary goal of a dose-finding trial for the novel anticancer agents is to identify an optimal dose (OD), defined as the tolerable dose having adequate efficacy under the unpredictable dose-toxicity and dose-efficacy relationships. It is also quite important to accelerate early-stage trials to shorten the entire period of drug development. To solve these issues, we propose the time-to-event Bayesian optimal interval design to accelerate dose-finding based on cumulative and pending data of both efficacy and toxicity. The new design, named “TITE-BOIN-ET” design, is nonparametric and a model-assisted design. A simulation study shows that the TITE-BOIN-ET design has advantages compared with the model-based approaches in both the percentage of correct OD selection and the average number of patients allocated to the ODs across a variety of realistic settings. In addition, the TITE-BOIN-ET design significantly shortens the trial duration compared with the designs without sequential enrollment and therefore has the potential to accelerate early-stage dose-finding trials.

Authors who are presenting talks have a * after their name.

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