Phase I clinical studies with cytotoxic drugs: pharmacokinetic and pharmacodynamic considerations
1990
Understanding Phase I Clinical Studies with Cancer Drugs
Sample size: 187
Editorial
Author Information
Author(s): D.R. Newell
Primary Institution: The University of Newcastle upon Tyne
Conclusion
Phase I studies often show low therapeutic benefit but are crucial for determining safe drug dosages.
Supporting Evidence
- Only 4.2% of patients in phase I studies showed an objective response.
- Most cytotoxic drugs are only effective at or near the maximum tolerated dose.
- Pharmacokinetic and pharmacodynamic factors contribute to the differences in drug efficacy between humans and animals.
Takeaway
When doctors test new cancer drugs, they start with small doses to see how much the body can handle, but this often doesn't help patients much.
Methodology
The article discusses the design and challenges of phase I clinical trials, focusing on pharmacokinetics and pharmacodynamics.
Limitations
The article highlights issues like assay sensitivity and inter-patient variability that complicate dose escalation.
Want to read the original?
Access the complete publication on the publisher's website