Linked Life Data

15477860

Source:http://linkedlifedata.com/resource/pubmed/id/15477860

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
10
pubmed:dateCreated
2004-11-10
pubmed:abstractText
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.
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-10699287, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-11454878, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-11489509, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-12417045, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-2039998, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-2306723, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-2946403, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-3162516, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-3556376, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-7602367, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-8313389, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-9060537, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-9262252, http://linkedlifedata.com/resource/pubmed/commentcorrection/15477860-9469358
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0007-0920
pubmed:author
pubmed:issnType
Print
pubmed:day
15
pubmed:volume
91
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1775-81
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
2004
pubmed:articleTitle
Phase I clinical trial and pharmacokinetic evaluation of NK911, a micelle-encapsulated doxorubicin.
pubmed:affiliation
Investigative Treatment Division, National Cancer Center Research Institute East, 6-5-1 Kashiwanoha, Kashiwa 277-8577, Japan. yhmatsum@east.ncc.go.jp
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase I