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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Authors | T Taguchi, A Wakui, H Niitani, H Furue, H Majima, I Nakao, K Ota, T Hattori, K Sugimachi |
Journal | Gan to kagaku ryoho. Cancer & chemotherapy
(Gan To Kagaku Ryoho)
Vol. 24
Issue 9
Pg. 1125-33
(Jul 1997)
ISSN: 0385-0684 [Print] Japan |
PMID | 9239166
(Publication Type: Clinical Trial, Clinical Trial, Phase I, English Abstract, Journal Article, Multicenter Study)
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Chemical References |
- Antibiotics, Antineoplastic
- Menogaril
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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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