Key result
Emetine hydrochloride fails to elicit responses in solid tumors and causes dose-limiting muscle weakness.
Why the study?
A Phase I clinical trial was conducted to evaluate the safety and tolerability of emetine hydrochloride in adults with solid tumors using two dosing schedules.
What is the maximum tolerable dose and toxicity profile of emetine hydrochloride in adults with solid tumors?
What is the maximum tolerable dose and toxicity profile of emetine hydrochloride in adults with solid tumors?
Emetine hydrochloride showed dose-limiting muscle weakness at a maximum tolerable total dose of 10 mg/kg, with no observed tumor response in adults with solid tumors.
Cautions against single-agent use at tested doses; leaves open refined schedules or combinations in solid tumors.
A Phase I clinical trial of emetine hydrochloride (NSC-33669) in adults with solid tumors was conducted using two time schedules: a. a single subcutaneous dose daily for 10 days, and b. a single subcutaneous injection every 4 days (q4d) for 10 doses. Thirty-two patients were treated on the daily schedule with doses ranging from 1.0–2.0 mg/kg/day, and nine patients were treated in the q4d schedule with doses ranging from 1.2–2.2 mg/kg/dose. Toxicity was similar in both groups and consisted of pain at the injection site, muscle weakness and myalgia, elevations in creatine phosphokinase, and electrocardiographic abnormalities. Muscle weakness was the dose-limiting toxicity. The maximum tolerable total dose was 10 mg/kg. No response was noted in 16 patients evaluated.
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Mastrangelo et al. (1973) studied solid tumors (n=41). emetine hydrochloride (NSC-33669) was evaluated on Toxicity and response. Emetine hydrochloride in adults with solid tumors had a maximum tolerable total dose of 10 mg/kg, with dose-limiting muscle weakness and no responses noted in 16 evaluated patients.
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