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A hybrid design for dose-finding oncology clinical trials
Jason J Z Liao1, Feng Zhou1, Heng Zhou2
1Incyte Corporation, Wilmington, Delaware, USA.
International Journal of Cancer
|July 8, 2022
Summary
A new hybrid design improves cancer drug dose-finding by combining existing methods. This approach better identifies the maximum tolerated dose (MTD) and recommended Phase II dose, enhancing patient safety and trial success.
Area of Science:
- Oncology
- Clinical Trial Design
- Biostatistics
Background:
- Accurate dose selection is critical for investigational cancer treatments to avoid trial failure or patient harm.
- Existing dose-finding designs have limitations that can be overcome by integrating their strengths.
Purpose of the Study:
- To propose and evaluate a novel hybrid dose-finding design for oncology clinical trials.
- To enhance the accuracy of determining the maximum tolerated dose (MTD) and recommended Phase II dose.
Main Methods:
- Developed a hybrid design integrating the modified toxicity probability interval (MTPI) design with a dose-toxicity model (logistic regression).
- Evaluated the hybrid design using a real clinical trial dataset and extensive simulation scenarios.
- Created an R-shiny tool for practical clinical application.
Main Results:
- The hybrid design effectively controlled overdosing toxicity.
- It recommended a Phase II dose closer to the true MTD by calibrating for intermediate doses.
- Demonstrated robust operating characteristics superior to existing designs in simulations.
Conclusions:
- The proposed hybrid design offers an effective and robust model for MTD and Phase II dose determination in oncology.
- The R-shiny tool enhances the practical feasibility and accessibility of this advanced dose-finding method.
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