Phase I and pharmacokinetic study of SM-5887, a new anthracycline derivative.
SM-5887, a new totally synthetic anthracycline derivative was studied in a phase I setting. Twenty-nine evaluable courses of treatment were conducted in groups at doses increasing from 10 to 130 mg/m2. Myelosuppression was the dose-limiting toxicity and a MTD was 130 mg/m2. At 130 mg/m2 the median lowest white blood cell count was 0.7 x 10(3)/cmm (range: 0.3-1.8) and the median lowest granulocyte count was 0.1 x 10(3)/cmm (range: 0-0.7) and the median lowest platelet count was 57 x 10(3)/cmm (range: 4-176). Non-hematologic side effects were mild gastrointestinal symptoms and hair loss. The recommended dose and schedule for phase II setting is 100 mg/m2 every 3 weeks.
Inoue
K
K
Dept. of Clinical Oncology, Cancer Institute Hospital, Japan.
Ogawa
M
M
Horikoshi
N
N
Mukaiyama
T
T
Itoh
Y
Y
Imajoh
K
K
Ozeki
H
H
Nagamine
D
D
Shinagawa
K
K
D000328:Adult; D000368:Aged; D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001772:Blood Cell Count; D004341:Drug Evaluation; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*
D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; C055866:amrubicin