[Phase I and pharmacokinetic study of SM-5887 by 5-day schedule].
Pharmacokinetics of SM-5887, a new totally synthetic anthracycline derivative, was studied in a phase I setting by 5-day schedule. The maximum tolerated dose was 25 mg/m2/d (total dose: 125 mg/m2/body) and the dose-limiting toxicity was myelosuppression which was consistent with the results of the phase I study by a single dose. In terms of subjective side effects, decreased nausea/vomiting and increased stomatitis were observed. In pharmacokinetic study, AUC of active form of SM-5887 increased on day 5 compared to that day 1. This result suggested that 5-day schedule of SM-5887 produced an accumulation of the active form. Five-day treatment schedule of SM-5887 seems to be more tolerable and further clinical study was recommended.
Inoue
K
K
Dept. of Clinical Oncology, Cancer Institute Hospital, Tokyo, Japan.
Matsumura
A
A
Horikoshi
N
N
Aiba
K
K
Mukaiyama
T
T
Matsumura
T
T
Ogihara
A
A
Sumida
T
T
Ogawa
M
M
D000328:Adult; D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D001853:Bone Marrow / Q000187:drug effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D008875:Middle Aged
D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; C055866:amrubicin