Literature DB >> 24828456

A Bayesian dose-finding design for drug combination clinical trials based on the logistic model.

Marie-Karelle Riviere1, Ying Yuan, Frédéric Dubois, Sarah Zohar.   

Abstract

In early phase dose-finding cancer studies, the objective is to determine the maximum tolerated dose, defined as the highest dose with an acceptable dose-limiting toxicity rate. Finding this dose for drug-combination trials is complicated because of drug-drug interactions, and many trial designs have been proposed to address this issue. These designs rely on complicated statistical models that typically are not familiar to clinicians, and are rarely used in practice. The aim of this paper is to propose a Bayesian dose-finding design for drug combination trials based on standard logistic regression. Under the proposed design, we continuously update the posterior estimates of the model parameters to make the decisions of dose assignment and early stopping. Simulation studies show that the proposed design is competitive and outperforms some existing designs. We also extend our design to handle delayed toxicities.
Copyright © 2014 John Wiley & Sons, Ltd.

Entities:  

Keywords:  Bayesian inference; dose finding; drug combination; oncology; phase I trial

Mesh:

Year:  2014        PMID: 24828456     DOI: 10.1002/pst.1621

Source DB:  PubMed          Journal:  Pharm Stat        ISSN: 1539-1604            Impact factor:   1.894


  21 in total

1.  Identifying a maximum tolerated contour in two-dimensional dose finding.

Authors:  Nolan A Wages
Journal:  Stat Med       Date:  2016-02-22       Impact factor: 2.373

2.  A Bayesian model-free approach to combination therapy phase I trials using censored time-to-toxicity data.

Authors:  Graham M Wheeler; Michael J Sweeting; Adrian P Mander
Journal:  J R Stat Soc Ser C Appl Stat       Date:  2018-11-22       Impact factor: 1.864

3.  A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies.

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4.  A practical Bayesian design to identify the maximum tolerated dose contour for drug combination trials.

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Journal:  Stat Med       Date:  2016-08-31       Impact factor: 2.373

Review 5.  Model-Assisted Designs for Early-Phase Clinical Trials: Simplicity Meets Superiority.

Authors:  Ying Yuan; J Jack Lee; Susan G Hilsenbeck
Journal:  JCO Precis Oncol       Date:  2019-10-24

6.  CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method.

Authors:  Mohamed Amine Bayar; Anastasia Ivanova; Gwénaël Le Teuff
Journal:  Comput Methods Programs Biomed       Date:  2019-05-06       Impact factor: 5.428

7.  AAA: triple adaptive Bayesian designs for the identification of optimal dose combinations in dual-agent dose finding trials.

Authors:  Jiaying Lyu; Yuan Ji; Naiqing Zhao; Daniel V T Catenacci
Journal:  J R Stat Soc Ser C Appl Stat       Date:  2018-06-13       Impact factor: 1.864

Review 8.  Practical designs for Phase I combination studies in oncology.

Authors:  Nolan A Wages; Anastasia Ivanova; Olga Marchenko
Journal:  J Biopharm Stat       Date:  2016       Impact factor: 1.051

9.  Dose Finding for Drug Combination in Early Cancer Phase I Trials using Conditional Continual Reassessment Method.

Authors:  Márcio Augusto Diniz; Mourad Tighiouart
Journal:  J Biom Biostat       Date:  2017-11-27

10.  A phase Ib dose-escalation study of the MEK inhibitor trametinib in combination with the PI3K/mTOR inhibitor GSK2126458 in patients with advanced solid tumors.

Authors:  J E Grilley-Olson; P L Bedard; A Fasolo; M Cornfeld; L Cartee; A R Abdul Razak; L-A Stayner; Y Wu; R Greenwood; R Singh; C B Lee; J Bendell; H A Burris; G Del Conte; C Sessa; J R Infante
Journal:  Invest New Drugs       Date:  2016-07-23       Impact factor: 3.850

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