論文

査読有り
2016年12月

Phase I study of NK105, a nanomicellar paclitaxel formulation, administered on a weekly schedule in patients with solid tumors

INVESTIGATIONAL NEW DRUGS
  • Hirofumi Mukai
  • ,
  • Ken Kato
  • ,
  • Taito Esaki
  • ,
  • Shouzou Ohsumi
  • ,
  • Yasuo Hozomi
  • ,
  • Nobuaki Matsubara
  • ,
  • Tetsuya Hamaguchi
  • ,
  • Yasuhiro Matsumura
  • ,
  • Rika Goda
  • ,
  • Takayuki Hirai
  • ,
  • Yoshihiro Nambu

34
6
開始ページ
750
終了ページ
759
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s10637-016-0381-4
出版者・発行元
SPRINGER

Previous studies have established the rationale for NK105, a nanomicellar formulation of paclitaxel, administered every 3 weeks. The aim of this phase I study was to determine the recommended dose and pharmacokinetics of weekly administered NK105. NK105 was administered by a 30-min infusion once weekly for three consecutive weeks in each 4-week cycle. In the dose-escalation phase, three to seven patients with solid tumors were enrolled to each of the four dose levels (50-100 mg/m(2); n = 16). At a dose level of 100 mg/m(2), predefined dose-limiting toxicity (DLT) manifested in only one out of six evaluable patients, whereas a dose delay due to neutropenia during the first course occurred two patients. None of the three patients given 80 mg/m(2) had a dose reduction, while a dose delay occurred in two. NK105 exhibited linear pharmacokinetics at doses of 50-100 mg/m(2), and approximately 5 % of total paclitaxel was released from micelles. Thus, the recommended dose was set at 80 mg/m(2), and an additional 10 advanced breast cancer (ABC) patients were given this dose in the dose-expansion phase. DLT manifested in two patients, and grade aeyen 3 neutropenia was found in eight patients. Among the nine patients who completed the first cycle, four had a dose reduction, mostly because of neutropenia. Of the 10 patients, six achieved partial response (PR), and four achieved stable disease (SD) status. Overall, weekly NK105 was well tolerated and had a desirable antitumor activity profile. Further investigations of NK105 in ABC patients are currently underway.

Web of Science ® 被引用回数 : 19

リンク情報
DOI
https://doi.org/10.1007/s10637-016-0381-4
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/27595901
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000387584100009&DestApp=WOS_CPL
ID情報
  • DOI : 10.1007/s10637-016-0381-4
  • ISSN : 0167-6997
  • eISSN : 1573-0646
  • PubMed ID : 27595901
  • Web of Science ID : WOS:000387584100009

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