Evaluating Rodent-Only Toxicology for Cancer Trials
Author Information
Author(s): Newell D R, Burtles S S, Fox B W, Jodrell D I, Connors T A
Primary Institution: Medical School, University of Newcastle, Newcastle, UK
Hypothesis
Can rodent-only toxicology studies effectively identify a safe starting dose for phase I clinical trials of cancer therapeutics?
Conclusion
Rodent-only toxicology studies can safely identify starting doses for phase I trials and predict common dose-limiting toxicities.
Supporting Evidence
- Rodent studies accurately predicted dose-limiting toxicities for 20 out of 25 drugs.
- The maximum tolerated dose in mice was associated with human toxicity in clinical trials.
- A safe starting dose for phase I trials was determined to be one-tenth the mouse MTD/LD10.
Takeaway
This study shows that using only rodents to test cancer drugs can help find safe starting doses for human trials.
Methodology
Data for 25 cancer drugs were analyzed to compare preclinical and clinical dosing and toxicity.
Limitations
The study may not account for all human toxicities, particularly those not assessable in rodents.
Digital Object Identifier (DOI)
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