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

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.
AuthorsT Taguchi, A Wakui, H Niitani, H Furue, H Majima, I Nakao, K Ota, T Hattori, K Sugimachi
JournalGan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 24 Issue 9 Pg. 1125-33 (Jul 1997) ISSN: 0385-0684 [Print] Japan
PMID9239166 (Publication Type: Clinical Trial, Clinical Trial, Phase I, English Abstract, Journal Article, Multicenter Study)
Chemical References
  • Antibiotics, Antineoplastic
  • Menogaril
Topics
  • Administration, Oral
  • Aged
  • Antibiotics, Antineoplastic (administration & dosage, blood, pharmacokinetics)
  • Breast Neoplasms (drug therapy, metabolism)
  • Colonic Neoplasms (drug therapy, metabolism)
  • Drug Administration Schedule
  • Female
  • Humans
  • Lung Neoplasms (drug therapy, metabolism)
  • Male
  • Menogaril (administration & dosage, blood, pharmacokinetics)
  • Middle Aged
  • Neoplasms (drug therapy, metabolism)
  • Pancreatic Neoplasms (drug therapy, metabolism)

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