ArticleClinical trials (London, England)2024
Dose optimization for cancer treatments with considerations for late-onset toxicities.
Article in Clinical trials (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
4 citing papers in PubMed.
- BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity.Therapeutic innovation & regulatory science · 2026Article
- Review
- Practical Considerations for Using the TITE-BOIN Design to Handle Late-Onset Toxicity or Fast Accrual in Phase I Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- T3 + 3: 3 + 3 Design With Delayed Outcomes.Pharmaceutical statisticsArticle
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Authors and funding
4 authors.
Funding
Abstract
Given that novel anticancer therapies have different toxicity profiles and mechanisms of action, it is important to reconsider the current approaches for dose selection. In an effort to move away from considering the maximum tolerated dose as the optimal dose, the Food and Drug Administration Project Optimus points to the need of incorporating long-term toxicity evaluation, given that many of these novel agents lead to late-onset or cumulative toxicities and there are no guidelines on how to handle them. Numerous methods have been proposed to handle late-onset toxicities in dose-finding clinical trials. A summary and comparison of these methods are provided. Moreover, using PI3K inhibitors as a case study, we show how late-onset toxicity can be integrated into the dose-optimization strategy using current available approaches. We illustrate a re-design of this trial to compare the approach to those that only consider early toxicity outcomes and disregard late-onset toxicities. We also provide proposals going forward for dose optimization in early development of novel anticancer agents with considerations for late-onset toxicities.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.