Phase I study of FK 435

O. Abe, K. Enomoto, K. Fujiwara, M. Izuo, Y. Iino, T. Tominaga, K. Hayashi, O. Takatani, N. Kugai, M. Yoshida

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5 Citations (Scopus)


We performed phase I study of FK 435, a new antiestrogen, in 30 patients with advanced breast cancer. Slight to moderate adverse reactions were noted as follows. Single-dose study: anorexia, nausea, lassitude in one patient (80 mg), decreased serum calcium in one (160 mg), redness, tenderness in one, facial flushing, hot flushes, headache in one (320 mg). Repeated-dose study: anorexia, nausea in one patient (40 mg/day), anorexia, diarrhea, increased FSH in one, increased PRL in one (80 mg/day). FK 435 was well tolerated. Tmax was 3-5 hours, T1/2 about 25 hours. Most of FK 435 was excreted into urine as glucuronide.

Original languageEnglish
Pages (from-to)903-913
Number of pages11
JournalGan no rinsho. Japan journal of cancer clinics
Issue number8
Publication statusPublished - 1990 Jul
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


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