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Controlled backfill in oncology dose-finding trials.

Hakim-Moulay Dehbi1, John O'Quigley2, Alexia Iasonos3

  • 1Comprehensive Clinical Trials Unit at UCL, London, UK.

Contemporary Clinical Trials
|November 8, 2021
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Summary
This summary is machine-generated.

This study introduces a new method for backfilling patients in early phase oncology trials to identify dose-efficacy plateaus. The approach helps recommend optimal, potentially lower, doses for future studies by analyzing pharmacokinetic and pharmacodynamic data.

Keywords:
BackfillContinual reassessment methodDose explorationDose-findingDose-rangingEarly phaseEfficacyOncologyPlateauResponse

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Area of Science:

  • Clinical Trials Methodology
  • Pharmacology
  • Oncology

Background:

  • Backfilling is a recent practice in early phase dose-finding trials.
  • It involves assigning patients to lower dose levels to gather more data.
  • The goal is to assess dose-efficacy curves, especially for targeted agents and immunotherapy in oncology.

Purpose of the Study:

  • To propose and evaluate a novel methodological framework for backfilling patients in early phase oncology trials.
  • To determine the optimal allocation strategy for backfill patients to dose levels.
  • To identify dose-efficacy plateaus and recommend appropriate doses for future studies.

Main Methods:

  • Randomizing backfill patients to dose levels below the current study level.
  • Sequentially stopping backfilling to lower doses if efficacy is insufficient.
  • Utilizing change point and monotonic models to analyze dose-response data from all patients.
  • Employing simulations to validate the proposed approach.

Main Results:

  • The proposed backfilling strategy can effectively identify plateaus on the dose-response curve.
  • Simulations demonstrate the method's ability to detect existing plateaus.
  • This allows for the recommendation of doses lower than the maximum tolerated dose for subsequent trials.

Conclusions:

  • The developed methodological framework provides a robust approach for designing and analyzing backfilling strategies in early phase oncology trials.
  • This method enhances the precision of dose selection by identifying optimal dose levels.
  • It supports informed decision-making for advancing promising therapies.