TY - JOUR
T1 - Phase I study of FK 435
AU - Abe, O.
AU - Enomoto, K.
AU - Fujiwara, K.
AU - Izuo, M.
AU - Iino, Y.
AU - Tominaga, T.
AU - Hayashi, K.
AU - Takatani, O.
AU - Kugai, N.
AU - Yoshida, M.
PY - 1990/7
Y1 - 1990/7
N2 - 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.
AB - 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.
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M3 - Article
C2 - 2195179
AN - SCOPUS:0025455806
SN - 0021-4949
VL - 36
SP - 903
EP - 913
JO - Gan no rinsho. Japan journal of cancer clinics
JF - Gan no rinsho. Japan journal of cancer clinics
IS - 8
ER -