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Dosage Regimens: Designs and Approaches01:28

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Dynamic ordering design for dose finding in drug-combination trials.

Teng Zhang1, Zhao Yang1, Guosheng Yin1,2

  • 1Department of Statistics and Actuarial Science, The University of Hong Kong, Hong Kong.

Pharmaceutical Statistics
|November 25, 2020
PubMed
Summary

This study introduces a novel dynamic ordering design (DOD) for oncology drug-combination trials. DOD improves toxicity evaluation and maximum tolerated dose (MTD) identification, offering a more efficient approach compared to existing methods.

Keywords:
Bayesian model selectiondose findingdrug combinationdynamic orderingmaximum tolerated dosenonparametric modeltoxicity order

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Area of Science:

  • Oncology
  • Clinical Trials
  • Biostatistics

Background:

  • Drug-combination studies are increasingly vital in oncology.
  • Phase I trials face challenges in accurately evaluating toxicity and identifying the maximum tolerated dose (MTD).
  • Existing designs often oversimplify the two-dimensional dose-finding space, leading to complex or lengthy trials.

Purpose of the Study:

  • To develop and evaluate a new dynamic ordering design (DOD) for dose-finding in phase I drug-combination trials.
  • To address the limitations of current MTD-finding strategies in complex trial settings.
  • To enhance the efficiency and safety of dose escalation in combination therapies.

Main Methods:

  • Developed two versions of a dynamic ordering design (DOD) within a Bayesian model selection framework.
  • Utilized a two-dimensional pool-adjacent-violators algorithm to continuously update toxicity orders.
  • Dose assignment for cohorts was based on the optimal model derived from the dynamic toxicity order.

Main Results:

  • Extensive simulations demonstrated that DOD achieved competitive performance in correct MTD selection.
  • DOD showed favorable safety profiles compared to four other commonly used designs.
  • The study illustrated the application of both DOD versions in two real-world oncology trials.

Conclusions:

  • The dynamic ordering design (DOD) offers a promising and efficient approach for dose-finding in phase I drug-combination oncology trials.
  • DOD effectively manages the complexities of two-dimensional dose-finding, improving MTD identification and patient safety.
  • The proposed methods provide a valuable alternative to existing designs, with demonstrated applicability in clinical settings.