1. Optimus-Era Dose Finding for Rare Cancers.
- Author
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Murciano-Goroff YR, Devlin SM, Iasonos A, and Drilon A
- Subjects
- Humans, Antineoplastic Agents therapeutic use, Antineoplastic Agents administration & dosage, Dose-Response Relationship, Drug, United States Food and Drug Administration, United States, Neoplasms drug therapy, Neoplasms diagnosis, Rare Diseases drug therapy, Rare Diseases diagnosis
- Abstract
Summary: Advances in cancer biology and diagnostics have led to the recognition of a multitude of rare cancer subtypes, emphasizing the pressing need for strategies to accelerate drug development for patients with these cancers. This paper addresses the unique challenges of dose finding in trials that accrue small numbers of patients with rare cancers; strategies for dose optimization are proposed, in line with evolving approaches to dose determination in the age of the US Food and Drug Administration's Project Optimus., (©2024 American Association for Cancer Research.)
- Published
- 2024
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