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Activity Number: 144
Type: Contributed
Date/Time: Monday, August 10, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #317205 View Presentation
Title: Phase I/II Oncology Study Design with Dose Escalation and Concomitant Dose Expansion
Author(s): Chaofeng Liu*
Companies:
Keywords: Onoclogy Phase I Design ; Dose Escalation ; Dose Expansion ; CRM
Abstract:

In a phase 1/2 oncology study, a modified 3+3 design with an accelerated titration is applied in the dose escalation phase and multiple doses can be concomitantly expanded for efficacy evaluation with positive efficacy signal. A 2-parameter Bayesian logistic regression is used to model the dose-toxicity relationship on DLT. The estimated DLT rates based on the Bayesian logistic regression model for each dose level will be provided as references for dose escalation procedure in dose escalation cohort and safety monitor in dose expansion cohort.

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

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