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A phase I study of toremifene.

T Tominaga1, O Abe, M Izuo

  • 1Tokyo Metropolitan Komagome Hospital, Japan.

Breast Cancer Research and Treatment
|August 1, 1990
PubMed
Summary
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This Phase I study evaluated toremifene, a new antiestrogenic drug, in Japanese women. Toremifene showed dose-dependent serum concentrations and mild side effects, indicating potential for further clinical trials.

Area of Science:

  • Pharmacology
  • Clinical Trials
  • Oncology

Background:

  • Antiestrogenic drugs are crucial in managing hormone-dependent cancers.
  • Toremifene is a novel agent with potential therapeutic applications.
  • Understanding its pharmacokinetic profile is essential for safe and effective use.

Purpose of the Study:

  • To assess the safety and tolerability of toremifene in Japanese women.
  • To determine the pharmacokinetic profile of orally administered toremifene.
  • To establish dose-ranging information for future studies.

Main Methods:

  • A Phase I clinical trial was conducted.
  • Twenty-seven Japanese women received oral toremifene.
  • Doses ranged from 10 to 480 mg daily for one or five days.

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Main Results:

  • Serum concentrations of toremifene demonstrated a dose-dependent increase.
  • Peak serum concentrations were achieved 2-6 hours post-administration.
  • Reported side effects were predominantly mild.

Conclusions:

  • Toremifene is generally well-tolerated in Japanese women at the studied doses.
  • The drug exhibits predictable pharmacokinetics.
  • These findings support further investigation of toremifene in larger clinical trials.