[TUT-7 phase I clinical study. TUT-7 Study Group].

T Taguchi; A Wakui; H Niitani; H Furue; H Majima; I Nakao; K Ota; T Hattori; K Sugimachi

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PubMed · 9239166

[TUT-7 phase I clinical study. TUT-7 Study Group].

T Taguchi·A Wakui·H Niitani·H Furue·H Majima·I Nakao·K Ota·T Hattori·K Sugimachi

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Abstract

A phase I study with TUT-7, a new anthracycline antitumor antibiotic, was conducted in 35 malignant tumor patients at 11 institutions nationwide. The study was initiated with a single dose at 100 mg/body which was equivalent to 2n, then the dose as escalated up to 700 mg/body in accordance with the modified Fibonacci's scheme. The dose limiting factor (DLF) was considered to be leukopenia, and maximum tolerated dose (MTD) was 700 mg/ body. The consecutive days dosing study subsequently conducted started with 25 mg/body/day, and the dose level was escalated up to 150 mg /body/day. TUT-7 was orally administered for seven (7) to fourteen (14) consecutive days in principle. It was considered that DLF was leukopenia and MTD was 100 mg/body/day for consecutive days dosing. The study indicated that serum drug concentrations reached their plateaus on the 5th day after initiation of TUT-7 treatment and the accumulation of this compound was low. With these findings, a regimen with a dose of 100 mg/body/day orally administered for 14 consecutive days was recommended for early phase II studies.

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Administration, Oral Aged Antibiotics, Antineoplastic Breast Neoplasms Colonic Neoplasms Drug Administration Schedule Female Humans Lung Neoplasms Male Menogaril Middle Aged Neoplasms Pancreatic Neoplasms Clinical Trial Clinical Trial, Phase I English Abstract Journal Article Multicenter Study

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T Taguchi, A Wakui, H Niitani, H Furue, H Majima, I Nakao, K Ota, T Hattori, K Sugimachi. 1997. [TUT-7 phase I clinical study. TUT-7 Study Group].. https://pubmed.ncbi.nlm.nih.gov/9239166/

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