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Activity Number: 674 - Adaptive Design - 3
Type: Contributed
Date/Time: Thursday, August 2, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #329504 Presentation
Title: A Bayesian Adaptive Phase 1/2 Design of Cisplatin and Cabazitaxel in Prostate Cancer with Visceral Metastasis
Author(s): Mourad Tighiouart*
Companies: Cedars-Sinai Medical Center
Keywords: Cancer Phase I/II trials; Maximum tolerated dose; Escalation with overdose control; Drug combination; Continuous dose; Bayesian adaptive design

We present a two-stage design of a combination of two drugs with continuous dose levels in advanced prostate cancer patients when the phase II population of patients is restricted to patients with visceral metastasis. The goal is to estimate dose combination regions that are tolerable and achieve the highest clinical benefit rate. In the first stage of the design, dose escalation is guided by first cycle dose limiting toxicity (DLT) and an estimate of the maximum tolerated dose (MTD) curve is obtained. In the second stage of the design, we propose a Bayesian adaptive design that allocates patients to dose combinations likely to be efficacious with the goal of identifying a final tolerable dose with the highest clinical benefit rate. The methodology is evaluated by presenting the operating characteristics under different scenarios for the true probability of treatment efficacy curve which include Bayesian power and type I error probabilities.

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

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