Abstract:
:NK911 is a novel supramolecular nanocarrier designed for the enhanced delivery of doxorubicin (DXR) and is one of the successful polymer micelle systems to exhibit an efficient accumulation in solid tumours in mice. The purpose of this study was to define the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of NK911 and to evaluate its pharmacokinetic profile in man. NK911 was given intravenously to patients with solid tumours every 3 weeks using an infusion pump at a rate of 10 mg DXR equivalent min(-1). The starting dose was 6 mg DXR equivalent m(-2), and the dose was escalated according to the accelerated titration method. A total of 23 patients participated in this study. Neutropenia was the predominant haematological toxicity, and grade 3 or 4 neutropenia was observed at doses of 50 and 67 mg m(-2). Common nonhaematological toxicities were mild alopecia, stomatitis, and anorexia. In the dose identification part of the study, DLTs were observed at a dose of 67 mg m(-2) (grade 4 neutropenia lasting more than 5 days). Thus, this dosage level was determined to be the MTD. Infusion-related reactions were not observed in any cases. The C(5 min) and area under the concentration curve parameters of NK911 exhibited dose-dependent characteristics. Among the 23 patients, a partial response was obtained in one patient with metastatic pancreatic cancer. NK911 was well tolerated and produced only moderate nausea and vomiting at myelosuppressive dosages. The recommended phase II dose was determined to be 50 mg m(-2) every 3 weeks.
journal_name
Br J Cancerjournal_title
British journal of cancerauthors
Matsumura Y,Hamaguchi T,Ura T,Muro K,Yamada Y,Shimada Y,Shirao K,Okusaka T,Ueno H,Ikeda M,Watanabe Ndoi
10.1038/sj.bjc.6602204subject
Has Abstractpub_date
2004-11-15 00:00:00pages
1775-81issue
10eissn
0007-0920issn
1532-1827pii
6602204journal_volume
91pub_type
临床试验,杂志文章abstract::RNA tumour virus genes are contained in the chromosomal DNA of most vertebrates, and may be transmitted vertically from parent to progeny along with other cellular genes, as well as horizontally as infectious particles. Activation of these viral genes may be part of the means by which RNA tumour viruses produce cancer...
journal_title:British journal of cancer
pub_type: 杂志文章,评审
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journal_title:British journal of cancer
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:British journal of cancer
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journal_title:British journal of cancer
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pub_type: 临床试验,杂志文章
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journal_title:British journal of cancer
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