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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-12

AUTHORS

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

ABSTRACT

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/m2; n = 16). At a dose level of 100 mg/m2, 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/m2 had a dose reduction, while a dose delay occurred in two. NK105 exhibited linear pharmacokinetics at doses of 50-100 mg/m2, and approximately 5 % of total paclitaxel was released from micelles. Thus, the recommended dose was set at 80 mg/m2, 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 ≥ 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. More... »

PAGES

750-759

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10637-016-0381-4

DOI

http://dx.doi.org/10.1007/s10637-016-0381-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1016363213

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/27595901


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Adult", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Aged, 80 and over", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Antineoplastic Agents, Phytogenic", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Drug Administration Schedule", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Female", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Follow-Up Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Male", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Maximum Tolerated Dose", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Middle Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Neoplasm Staging", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Neoplasms", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Paclitaxel", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Prognosis", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Survival Rate", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Tissue Distribution", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "National Cancer Center Hospital East", 
          "id": "https://www.grid.ac/institutes/grid.497282.2", 
          "name": [
            "Department of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, 277-8577, Chiba, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Mukai", 
        "givenName": "Hirofumi", 
        "id": "sg:person.0646216705.29", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0646216705.29"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "National Cancer Centre", 
          "id": "https://www.grid.ac/institutes/grid.272242.3", 
          "name": [
            "Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, National Cancer Center, Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Kato", 
        "givenName": "Ken", 
        "id": "sg:person.015410150542.42", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.015410150542.42"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "National Hospital Organization Kyushu Cancer Center", 
          "id": "https://www.grid.ac/institutes/grid.470350.5", 
          "name": [
            "Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Esaki", 
        "givenName": "Taito", 
        "id": "sg:person.01272613253.50", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01272613253.50"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Shikoku Cancer Center", 
          "id": "https://www.grid.ac/institutes/grid.415740.3", 
          "name": [
            "Department of Breast Surgery, National Hospital Organization Shikoku Cancer Center, Ehime, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ohsumi", 
        "givenName": "Shouzou", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "University of Tsukuba Hospital", 
          "id": "https://www.grid.ac/institutes/grid.412814.a", 
          "name": [
            "Department of Breast and Endocrine Surgery, University of Tsukuba Hospital, Ibaragi, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hozomi", 
        "givenName": "Yasuo", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "National Cancer Center Hospital East", 
          "id": "https://www.grid.ac/institutes/grid.497282.2", 
          "name": [
            "Department of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, 277-8577, Chiba, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Matsubara", 
        "givenName": "Nobuaki", 
        "id": "sg:person.01346166016.16", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01346166016.16"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "National Cancer Centre", 
          "id": "https://www.grid.ac/institutes/grid.272242.3", 
          "name": [
            "Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, National Cancer Center, Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hamaguchi", 
        "givenName": "Tetsuya", 
        "id": "sg:person.01345240561.31", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01345240561.31"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "National Cancer Centre", 
          "id": "https://www.grid.ac/institutes/grid.272242.3", 
          "name": [
            "Division of Developmental Therapeutics, National Cancer Center Hospital East, Chiba, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Matsumura", 
        "givenName": "Yasuhiro", 
        "id": "sg:person.013241054552.08", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.013241054552.08"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Nippon Kayaku (Japan)", 
          "id": "https://www.grid.ac/institutes/grid.420035.0", 
          "name": [
            "Nippon Kayaku Co., Ltd., Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Goda", 
        "givenName": "Rika", 
        "id": "sg:person.014425003525.35", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014425003525.35"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Nippon Kayaku (Japan)", 
          "id": "https://www.grid.ac/institutes/grid.420035.0", 
          "name": [
            "Nippon Kayaku Co., Ltd., Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hirai", 
        "givenName": "Takayuki", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Nippon Kayaku (Japan)", 
          "id": "https://www.grid.ac/institutes/grid.420035.0", 
          "name": [
            "Nippon Kayaku Co., Ltd., Tokyo, Japan"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Nambu", 
        "givenName": "Yoshihiro", 
        "id": "sg:person.01315366661.53", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01315366661.53"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1007/s10637-011-9709-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004450762", 
          "https://doi.org/10.1007/s10637-011-9709-2"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s10637-011-9709-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004450762", 
          "https://doi.org/10.1007/s10637-011-9709-2"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.2147/ijn.s41770", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009663400"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0140-6736(00)02074-2", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1013379406"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1349-7006.1995.tb03316.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1018199137"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1349-7006.1995.tb03316.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1018199137"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/sj.bjc.6603855", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1022320679", 
          "https://doi.org/10.1038/sj.bjc.6603855"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/annonc/mdu385", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024164086"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/sj.bjc.6602479", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031917901", 
          "https://doi.org/10.1038/sj.bjc.6602479"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/sj.bjc.6602479", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031917901", 
          "https://doi.org/10.1038/sj.bjc.6602479"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0168-3659(01)00341-8", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040228931"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s0168-3659(99)00248-5", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1044151490"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2007.11.6699", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1051399808"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/biomet/26.4.404", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1059415719"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/jnci/82.15.1247", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1059815936"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1077880120", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1079469205", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1083036648", 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1002/9780470317051", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1109496277"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://app.dimensions.ai/details/publication/pub.1109496277", 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2016-12", 
    "datePublishedReg": "2016-12-01", 
    "description": "Previous studies have established the rationale for NK105, a nanomicellar formulation of paclitaxel, administered every 3\u00a0weeks. 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\u00a0cycle. In the dose-escalation phase, three to seven patients with solid tumors were enrolled to each of the four dose levels (50-100\u00a0mg/m2; n\u00a0=\u00a016). At a dose level of 100\u00a0mg/m2, 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\u00a0mg/m2 had a dose reduction, while a dose delay occurred in two. NK105 exhibited linear pharmacokinetics at doses of 50-100\u00a0mg/m2, and approximately 5\u00a0% of total paclitaxel was released from micelles. Thus, the recommended dose was set at 80\u00a0mg/m2, 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\u00a0\u2265\u00a03 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.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1007/s10637-016-0381-4", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1094201", 
        "issn": [
          "0167-6997", 
          "1573-0646"
        ], 
        "name": "Investigational New Drugs", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "6", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "34"
      }
    ], 
    "name": "Phase I study of NK105, a nanomicellar paclitaxel formulation, administered on a weekly schedule in patients with solid tumors", 
    "pagination": "750-759", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "4df72f60785b44f9588ea5ad33943fbf81610408472955260ca85c6dc13c7d3e"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "27595901"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "8309330"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1007/s10637-016-0381-4"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1016363213"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1007/s10637-016-0381-4", 
      "https://app.dimensions.ai/details/publication/pub.1016363213"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-11T12:42", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-uberresearch-data-dimensions-target-20181106-alternative/cleanup/v134/2549eaecd7973599484d7c17b260dba0a4ecb94b/merge/v9/a6c9fde33151104705d4d7ff012ea9563521a3ce/jats-lookup/v90/0000000363_0000000363/records_70061_00000000.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://link.springer.com/10.1007%2Fs10637-016-0381-4"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s10637-016-0381-4'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s10637-016-0381-4'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s10637-016-0381-4'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s10637-016-0381-4'


 

This table displays all metadata directly associated to this object as RDF triples.

270 TRIPLES      21 PREDICATES      63 URIs      38 LITERALS      26 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1007/s10637-016-0381-4 schema:about N2536d20371684749bc749d7b2c06a163
2 N282f068e71444713a3b48792fd175703
3 N3188e2c279d444df9cdc0480d3a87894
4 N3b116ec791be49d0b92b570c3eb783aa
5 N3e46fd86df9a4d4aa7f158e2e0fd0a86
6 N46e5375ffada4abcaf881e96e40dc7e2
7 N727cadc31fb749608864652e5d0b3625
8 N781901420f9043609bc98de5ca370dfe
9 N82e5e1c854564ce394bd9d9796c7effe
10 N8753012d1a9b40368a60d0fcce67b3bb
11 N88afd04bf6ef48d1bc169bee1e01a45a
12 N946a270e5c99415d9256b7fe59105d59
13 Nc77e9fe5d2e941a78bf233f2c09ccd2e
14 Nce1ed77d32824f2eafc75a2f7fc03cf9
15 Ndccffac05c7140ada35df5f6613b8c27
16 Nf30a83137ffe49feadaeba8cd4be5f9d
17 Nfb7ea034c4c3406e84b5baf8e276979a
18 anzsrc-for:11
19 anzsrc-for:1103
20 schema:author N354e5220c7c941e9ab0304125ac040ce
21 schema:citation sg:pub.10.1007/s10637-011-9709-2
22 sg:pub.10.1038/sj.bjc.6602479
23 sg:pub.10.1038/sj.bjc.6603855
24 https://app.dimensions.ai/details/publication/pub.1077880120
25 https://app.dimensions.ai/details/publication/pub.1079469205
26 https://app.dimensions.ai/details/publication/pub.1083036648
27 https://app.dimensions.ai/details/publication/pub.1109496277
28 https://doi.org/10.1002/9780470317051
29 https://doi.org/10.1016/s0140-6736(00)02074-2
30 https://doi.org/10.1016/s0168-3659(01)00341-8
31 https://doi.org/10.1016/s0168-3659(99)00248-5
32 https://doi.org/10.1093/annonc/mdu385
33 https://doi.org/10.1093/biomet/26.4.404
34 https://doi.org/10.1093/jnci/82.15.1247
35 https://doi.org/10.1111/j.1349-7006.1995.tb03316.x
36 https://doi.org/10.1200/jco.2007.11.6699
37 https://doi.org/10.2147/ijn.s41770
38 schema:datePublished 2016-12
39 schema:datePublishedReg 2016-12-01
40 schema:description 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<sup>2</sup>; n = 16). At a dose level of 100 mg/m<sup>2</sup>, 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<sup>2</sup> had a dose reduction, while a dose delay occurred in two. NK105 exhibited linear pharmacokinetics at doses of 50-100 mg/m<sup>2</sup>, and approximately 5 % of total paclitaxel was released from micelles. Thus, the recommended dose was set at 80 mg/m<sup>2</sup>, 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 ≥ 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.
41 schema:genre research_article
42 schema:inLanguage en
43 schema:isAccessibleForFree true
44 schema:isPartOf N6a458ed3d13e4578b7e9469583d4b4eb
45 N7d92271599fa48a98d6b0bab162009e3
46 sg:journal.1094201
47 schema:name Phase I study of NK105, a nanomicellar paclitaxel formulation, administered on a weekly schedule in patients with solid tumors
48 schema:pagination 750-759
49 schema:productId N0b63c6a35a154fcdb75f158d864092ca
50 N7b712c35a16146dea7ab53cba9804be5
51 Nb66e27dff58c4f12bd7fb0f78e86217c
52 Nd70a8e0eb74546e981f3dfe58f54ede0
53 Ned5d9944973d48d08fa17d13548a4d02
54 schema:sameAs https://app.dimensions.ai/details/publication/pub.1016363213
55 https://doi.org/10.1007/s10637-016-0381-4
56 schema:sdDatePublished 2019-04-11T12:42
57 schema:sdLicense https://scigraph.springernature.com/explorer/license/
58 schema:sdPublisher N6655a17e3ea54ffeae0fabf8bc494d36
59 schema:url https://link.springer.com/10.1007%2Fs10637-016-0381-4
60 sgo:license sg:explorer/license/
61 sgo:sdDataset articles
62 rdf:type schema:ScholarlyArticle
63 N0b63c6a35a154fcdb75f158d864092ca schema:name pubmed_id
64 schema:value 27595901
65 rdf:type schema:PropertyValue
66 N0bd85452d79043499a16e690ea366fcd rdf:first sg:person.01345240561.31
67 rdf:rest Nac837d21a7e642dd8a4a00f8bf0e770a
68 N1bb4dddbb7d94b418e4fa76899b06230 rdf:first Nd1c122fd6f0e4f45a950ae8ee06db6c4
69 rdf:rest N908c8729f51049d8bebf7e0e00b83ec5
70 N2536d20371684749bc749d7b2c06a163 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
71 schema:name Humans
72 rdf:type schema:DefinedTerm
73 N282f068e71444713a3b48792fd175703 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
74 schema:name Adult
75 rdf:type schema:DefinedTerm
76 N3188e2c279d444df9cdc0480d3a87894 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
77 schema:name Drug Administration Schedule
78 rdf:type schema:DefinedTerm
79 N354e5220c7c941e9ab0304125ac040ce rdf:first sg:person.0646216705.29
80 rdf:rest N9e5443c592b044b9a5367954277df052
81 N3b116ec791be49d0b92b570c3eb783aa schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
82 schema:name Aged, 80 and over
83 rdf:type schema:DefinedTerm
84 N3e46fd86df9a4d4aa7f158e2e0fd0a86 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
85 schema:name Paclitaxel
86 rdf:type schema:DefinedTerm
87 N432fbb6302f24d33b3dc087343c25169 rdf:first sg:person.01272613253.50
88 rdf:rest N1bb4dddbb7d94b418e4fa76899b06230
89 N46e5375ffada4abcaf881e96e40dc7e2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
90 schema:name Neoplasms
91 rdf:type schema:DefinedTerm
92 N47af831718f54d089f22777cbf8a9d8e rdf:first Nbfb930c059334cb59d1b25bc7b8f5140
93 rdf:rest N864be23ccf054487b928013bb4ae76ab
94 N4d02f2b85097414a8a98bfee8b33f3e3 rdf:first sg:person.01346166016.16
95 rdf:rest N0bd85452d79043499a16e690ea366fcd
96 N59f5c0257b014c3a89e5b99cd7a90aa0 rdf:first sg:person.014425003525.35
97 rdf:rest N47af831718f54d089f22777cbf8a9d8e
98 N6655a17e3ea54ffeae0fabf8bc494d36 schema:name Springer Nature - SN SciGraph project
99 rdf:type schema:Organization
100 N6a458ed3d13e4578b7e9469583d4b4eb schema:volumeNumber 34
101 rdf:type schema:PublicationVolume
102 N727cadc31fb749608864652e5d0b3625 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
103 schema:name Male
104 rdf:type schema:DefinedTerm
105 N781901420f9043609bc98de5ca370dfe schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
106 schema:name Middle Aged
107 rdf:type schema:DefinedTerm
108 N7b712c35a16146dea7ab53cba9804be5 schema:name dimensions_id
109 schema:value pub.1016363213
110 rdf:type schema:PropertyValue
111 N7d92271599fa48a98d6b0bab162009e3 schema:issueNumber 6
112 rdf:type schema:PublicationIssue
113 N82e5e1c854564ce394bd9d9796c7effe schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
114 schema:name Follow-Up Studies
115 rdf:type schema:DefinedTerm
116 N864be23ccf054487b928013bb4ae76ab rdf:first sg:person.01315366661.53
117 rdf:rest rdf:nil
118 N8753012d1a9b40368a60d0fcce67b3bb schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
119 schema:name Tissue Distribution
120 rdf:type schema:DefinedTerm
121 N88afd04bf6ef48d1bc169bee1e01a45a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
122 schema:name Antineoplastic Agents, Phytogenic
123 rdf:type schema:DefinedTerm
124 N908c8729f51049d8bebf7e0e00b83ec5 rdf:first Nb51087c3691141e48c8fe374a7b1f4da
125 rdf:rest N4d02f2b85097414a8a98bfee8b33f3e3
126 N946a270e5c99415d9256b7fe59105d59 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
127 schema:name Neoplasm Staging
128 rdf:type schema:DefinedTerm
129 N9e5443c592b044b9a5367954277df052 rdf:first sg:person.015410150542.42
130 rdf:rest N432fbb6302f24d33b3dc087343c25169
131 Nac837d21a7e642dd8a4a00f8bf0e770a rdf:first sg:person.013241054552.08
132 rdf:rest N59f5c0257b014c3a89e5b99cd7a90aa0
133 Nb51087c3691141e48c8fe374a7b1f4da schema:affiliation https://www.grid.ac/institutes/grid.412814.a
134 schema:familyName Hozomi
135 schema:givenName Yasuo
136 rdf:type schema:Person
137 Nb66e27dff58c4f12bd7fb0f78e86217c schema:name doi
138 schema:value 10.1007/s10637-016-0381-4
139 rdf:type schema:PropertyValue
140 Nbfb930c059334cb59d1b25bc7b8f5140 schema:affiliation https://www.grid.ac/institutes/grid.420035.0
141 schema:familyName Hirai
142 schema:givenName Takayuki
143 rdf:type schema:Person
144 Nc77e9fe5d2e941a78bf233f2c09ccd2e schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
145 schema:name Maximum Tolerated Dose
146 rdf:type schema:DefinedTerm
147 Nce1ed77d32824f2eafc75a2f7fc03cf9 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
148 schema:name Prognosis
149 rdf:type schema:DefinedTerm
150 Nd1c122fd6f0e4f45a950ae8ee06db6c4 schema:affiliation https://www.grid.ac/institutes/grid.415740.3
151 schema:familyName Ohsumi
152 schema:givenName Shouzou
153 rdf:type schema:Person
154 Nd70a8e0eb74546e981f3dfe58f54ede0 schema:name readcube_id
155 schema:value 4df72f60785b44f9588ea5ad33943fbf81610408472955260ca85c6dc13c7d3e
156 rdf:type schema:PropertyValue
157 Ndccffac05c7140ada35df5f6613b8c27 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
158 schema:name Aged
159 rdf:type schema:DefinedTerm
160 Ned5d9944973d48d08fa17d13548a4d02 schema:name nlm_unique_id
161 schema:value 8309330
162 rdf:type schema:PropertyValue
163 Nf30a83137ffe49feadaeba8cd4be5f9d schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
164 schema:name Survival Rate
165 rdf:type schema:DefinedTerm
166 Nfb7ea034c4c3406e84b5baf8e276979a schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
167 schema:name Female
168 rdf:type schema:DefinedTerm
169 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
170 schema:name Medical and Health Sciences
171 rdf:type schema:DefinedTerm
172 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
173 schema:name Clinical Sciences
174 rdf:type schema:DefinedTerm
175 sg:journal.1094201 schema:issn 0167-6997
176 1573-0646
177 schema:name Investigational New Drugs
178 rdf:type schema:Periodical
179 sg:person.01272613253.50 schema:affiliation https://www.grid.ac/institutes/grid.470350.5
180 schema:familyName Esaki
181 schema:givenName Taito
182 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01272613253.50
183 rdf:type schema:Person
184 sg:person.01315366661.53 schema:affiliation https://www.grid.ac/institutes/grid.420035.0
185 schema:familyName Nambu
186 schema:givenName Yoshihiro
187 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01315366661.53
188 rdf:type schema:Person
189 sg:person.013241054552.08 schema:affiliation https://www.grid.ac/institutes/grid.272242.3
190 schema:familyName Matsumura
191 schema:givenName Yasuhiro
192 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.013241054552.08
193 rdf:type schema:Person
194 sg:person.01345240561.31 schema:affiliation https://www.grid.ac/institutes/grid.272242.3
195 schema:familyName Hamaguchi
196 schema:givenName Tetsuya
197 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01345240561.31
198 rdf:type schema:Person
199 sg:person.01346166016.16 schema:affiliation https://www.grid.ac/institutes/grid.497282.2
200 schema:familyName Matsubara
201 schema:givenName Nobuaki
202 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01346166016.16
203 rdf:type schema:Person
204 sg:person.014425003525.35 schema:affiliation https://www.grid.ac/institutes/grid.420035.0
205 schema:familyName Goda
206 schema:givenName Rika
207 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014425003525.35
208 rdf:type schema:Person
209 sg:person.015410150542.42 schema:affiliation https://www.grid.ac/institutes/grid.272242.3
210 schema:familyName Kato
211 schema:givenName Ken
212 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.015410150542.42
213 rdf:type schema:Person
214 sg:person.0646216705.29 schema:affiliation https://www.grid.ac/institutes/grid.497282.2
215 schema:familyName Mukai
216 schema:givenName Hirofumi
217 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0646216705.29
218 rdf:type schema:Person
219 sg:pub.10.1007/s10637-011-9709-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1004450762
220 https://doi.org/10.1007/s10637-011-9709-2
221 rdf:type schema:CreativeWork
222 sg:pub.10.1038/sj.bjc.6602479 schema:sameAs https://app.dimensions.ai/details/publication/pub.1031917901
223 https://doi.org/10.1038/sj.bjc.6602479
224 rdf:type schema:CreativeWork
225 sg:pub.10.1038/sj.bjc.6603855 schema:sameAs https://app.dimensions.ai/details/publication/pub.1022320679
226 https://doi.org/10.1038/sj.bjc.6603855
227 rdf:type schema:CreativeWork
228 https://app.dimensions.ai/details/publication/pub.1077880120 schema:CreativeWork
229 https://app.dimensions.ai/details/publication/pub.1079469205 schema:CreativeWork
230 https://app.dimensions.ai/details/publication/pub.1083036648 schema:CreativeWork
231 https://app.dimensions.ai/details/publication/pub.1109496277 schema:CreativeWork
232 https://doi.org/10.1002/9780470317051 schema:sameAs https://app.dimensions.ai/details/publication/pub.1109496277
233 rdf:type schema:CreativeWork
234 https://doi.org/10.1016/s0140-6736(00)02074-2 schema:sameAs https://app.dimensions.ai/details/publication/pub.1013379406
235 rdf:type schema:CreativeWork
236 https://doi.org/10.1016/s0168-3659(01)00341-8 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040228931
237 rdf:type schema:CreativeWork
238 https://doi.org/10.1016/s0168-3659(99)00248-5 schema:sameAs https://app.dimensions.ai/details/publication/pub.1044151490
239 rdf:type schema:CreativeWork
240 https://doi.org/10.1093/annonc/mdu385 schema:sameAs https://app.dimensions.ai/details/publication/pub.1024164086
241 rdf:type schema:CreativeWork
242 https://doi.org/10.1093/biomet/26.4.404 schema:sameAs https://app.dimensions.ai/details/publication/pub.1059415719
243 rdf:type schema:CreativeWork
244 https://doi.org/10.1093/jnci/82.15.1247 schema:sameAs https://app.dimensions.ai/details/publication/pub.1059815936
245 rdf:type schema:CreativeWork
246 https://doi.org/10.1111/j.1349-7006.1995.tb03316.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1018199137
247 rdf:type schema:CreativeWork
248 https://doi.org/10.1200/jco.2007.11.6699 schema:sameAs https://app.dimensions.ai/details/publication/pub.1051399808
249 rdf:type schema:CreativeWork
250 https://doi.org/10.2147/ijn.s41770 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009663400
251 rdf:type schema:CreativeWork
252 https://www.grid.ac/institutes/grid.272242.3 schema:alternateName National Cancer Centre
253 schema:name Division of Developmental Therapeutics, National Cancer Center Hospital East, Chiba, Japan
254 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, National Cancer Center, Tokyo, Japan
255 rdf:type schema:Organization
256 https://www.grid.ac/institutes/grid.412814.a schema:alternateName University of Tsukuba Hospital
257 schema:name Department of Breast and Endocrine Surgery, University of Tsukuba Hospital, Ibaragi, Japan
258 rdf:type schema:Organization
259 https://www.grid.ac/institutes/grid.415740.3 schema:alternateName Shikoku Cancer Center
260 schema:name Department of Breast Surgery, National Hospital Organization Shikoku Cancer Center, Ehime, Japan
261 rdf:type schema:Organization
262 https://www.grid.ac/institutes/grid.420035.0 schema:alternateName Nippon Kayaku (Japan)
263 schema:name Nippon Kayaku Co., Ltd., Tokyo, Japan
264 rdf:type schema:Organization
265 https://www.grid.ac/institutes/grid.470350.5 schema:alternateName National Hospital Organization Kyushu Cancer Center
266 schema:name Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan
267 rdf:type schema:Organization
268 https://www.grid.ac/institutes/grid.497282.2 schema:alternateName National Cancer Center Hospital East
269 schema:name Department of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, 277-8577, Chiba, Japan
270 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...