Phase I Study of Amphethinile
Author Information
Author(s): D.B. Smith, C. Ewen, J. Mackintosh, B.W. Fox, N. Thatcher, J.H. Scarff, R. Vezin, D. Crowther
Primary Institution: CRC Department of Medical Oncology, Christie Hospital and Holt Radium Institute
Hypothesis
Can amphethinile be safely administered to patients with solid tumors that have failed conventional therapy?
Conclusion
Amphethinile cannot be recommended for phase II testing by the intravenous route due to unpredictable toxicities.
Supporting Evidence
- Amphethinile showed activity in rodent tumors but caused significant toxic effects at higher doses.
- Two patients died within 48 hours of treatment at the highest dose, raising safety concerns.
- Neutropenia and alopecia were observed in some patients, indicating potential side effects.
Takeaway
Researchers tested a new drug called amphethinile on patients with cancer, but it caused serious side effects, so they decided not to use it further.
Methodology
The study involved a phase I clinical trial with dose escalation based on pharmacological monitoring.
Potential Biases
The formulation vehicle, solutol, had not been previously tested in humans, raising safety concerns.
Limitations
The trial was terminated due to severe toxicities and deaths at the highest dose.
Participant Demographics
Patients had solid tumors that failed conventional therapy, with a median age of 51 years (range 24-69) and a sex ratio of 8 males to 7 females.
Want to read the original?
Access the complete publication on the publisher's website