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Phase I trial of N-methylformamide
Cancer Treatment Reports
|April 1, 1984
Summary
N-methylformamide showed good oral absorption and manageable side effects like nausea in a Phase I study. The recommended dose for further trials is 800 mg/m2/day orally.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- N-methylformamide is an antineoplastic agent.
- Phase I studies are crucial for evaluating drug safety and dosage in humans.
Purpose of the Study:
- To assess the safety, tolerability, and bioavailability of N-methylformamide.
- To determine the recommended dose for Phase II trials.
Main Methods:
- Intravenous and oral administration of N-methylformamide to 19 patients.
- Dose escalation from 300 mg/m2/day to 1200 mg/m2/day (X 5).
- Monitoring for toxic effects, bioavailability, and therapeutic response.
Main Results:
- Nausea and vomiting were the principal toxic effects, manageable with oral administration.
- Excellent oral absorption was confirmed.
- Reversible hyperbilirubinemia was the dose-limiting toxicity; one patient experienced jaundice.
- Two partial responses (prostate, cervix) and two minimal responses (ovarian, hypernephroma) were observed.
Conclusions:
- N-methylformamide is well-absorbed orally with manageable toxicity.
- The recommended Phase II dose is 800 mg/m2/day orally for 5 days, repeated every 2-3 weeks.