Phase I clinical and pharmacokinetic study of orally administeredN4-palmitoyl-1-β-d-arabinofuranosylcytosine View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

1987-06

AUTHORS

Ryuzo Ohno, Kiyoji Kimura, Kazuo Ota, Yasusada Miura, Akira Hoshino, Kenichi Hattori, Masami Hirano, Munemoto Ito, Tadashi Maekawa, Toru Nakamura, Ikuo Kimura, Michito Ichimaru, Yoshiro Uzuka, Masao Oguro, Tamotsu Miyazaki, Yasunobu Sakai, Yutaka Hirota, Ichita Amaki, Shigeyuki Osamura, Toru Masaoka, Fumimaro Takaku, Kazumasa Yamada

ABSTRACT

A phase I study ofN4-palmitoyl-1-β-d-arabinofuranosylcytosine (PLAC) was conducted in 88 patients; 36 with solid tumors and 52 with hematological malignancies, using 2 different schedules. Schedule 1 employed a single oral administration and Schedule 2, 5-day consecutive daily oral administration. In Schedule 1, the daily dose was initiated with 1 mg kg−1 which was escalated up to 24 mg kg−1 according to the modified Fibonacci’s method. Side effects included nausea, vomiting and skin rashes, but myelosuppression was not seen within this dose range. In Schedule 2, the daily dose was started with 1 mg kg−1 which was escalated up to 24 mg kg−1. Major side effects were nausea, vomiting and amorexia, and mild myelosuppression was noted at 12 mg kg−1 or more. The dose-limiting toxicity was gastrointestinal toxicity, which appeared at 3.3 mg kg−1 or more and became frequent at 7 mg kg−1 or more. Pharmacokinetic study revealed that the plasma concentrations of PLAC and ara-C, obtained by the oral intake of 3.3 mg kg−1 or more of PLAC, were sufficient for these compounds to exert cytotoxic effects on various human leukemia cellsin vitro. Based on these observations and plausible mechanism of action of PLAC, further clinical study should be carried out in a treatment schedule of considerably prolonged administration period with 3.3–6 mg kg−1 day−1 of PLAC. More... »

PAGES

67-73

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/bf02934942

DOI

http://dx.doi.org/10.1007/bf02934942

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1079887600

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/3669779


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