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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Agonists can bind with and activate receptors, resulting in the formation of drug-receptor complexes. Once formed, these complexes catalyze many biochemical processes at the cellular level and subsequently induce a pharmacologic response. The degree of response is directly proportional to the fraction of activated receptors, which in turn, depends on the concentration of the drug at the receptor site as well as the sensitivity of the receptor. An increase in the administered dose contributes to...
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Drugs exert their therapeutic effects by interacting with receptors, enzymes, or ion channels that are present throughout the human body. The strength and duration of the interaction between a drug and its target receptor are characterized by the selectivity and specificity of the drug. Selectivity refers to a drug's strong preference for its intended target over other targets. For instance, isoprenaline, a non-selective β-adrenergic agonist, interacts with both β1- and...
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Controlled amplification in oncology dose-finding trials.

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

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

Contemporary Clinical Trials
|December 16, 2022
PubMed
Summary
This summary is machine-generated.

This study explores "controlled amplification" in oncology clinical trials, using dose expansion cohorts and backfill patients to gather more data on lower doses. This approach helps determine the recommended Phase 2 dose (RP2D) more effectively.

Keywords:
AmplificationBackfillDose-findingEarly phase trialsExpansionOncologyRandomisationSelection

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Area of Science:

  • Oncology
  • Clinical Trial Design
  • Pharmacometrics

Background:

  • Traditional oncology trials focus on identifying the maximum tolerated dose (MTD) for cytotoxic agents.
  • Modern early-phase trials for non-cytotoxic agents incorporate multiple objectives, including determining the recommended Phase 2 dose (RP2D).
  • Conventional methods like the Continual Reassessment Method (CRM) collect limited data on doses below the MTD.

Purpose of the Study:

  • To investigate the concept of "controlled amplification" in dose-finding designs.
  • To precisely define and analyze methods that amplify data collection at lower dose levels.
  • To evaluate a specific design that utilizes controlled amplification for improved RP2D determination.

Main Methods:

  • Review and definition of "controlled amplification" strategies.
  • Inclusion of dose expansion cohorts and patient backfilling as amplification methods.
  • Analysis of a novel dose-finding design incorporating controlled amplification.

Main Results:

  • Controlled amplification, through dose expansion and backfilling, enhances data collection on doses near and below the MTD.
  • This strategy addresses the possibility that lower doses may be more effective ("less is more").
  • The study presents observations and evaluates a specific design exploiting controlled amplification.

Conclusions:

  • Controlled amplification is a valuable strategy for modern oncology dose-finding trials.
  • These methods improve the efficiency and information yield for RP2D determination.
  • Further investigation into specific designs utilizing controlled amplification is warranted.