Lack of food effect on single-dose pharmacokinetics of brivanib, and safety and efficacy following multiple doses in subjects with advanced ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2011-12

AUTHORS

Patricia LoRusso, Geoffrey I. Shapiro, Herbert Hurwitz, Mary Jo Pilat, Janice Chemidlin, Georgia Kollia, Shariq Syed, Bruce Fischer, Eric Masson

ABSTRACT

PURPOSE: Brivanib alaninate, an orally available prodrug of brivanib, is currently under evaluation for the treatment of several malignancies. This study aimed to (1) investigate effects of a high-fat meal on single-dose pharmacokinetics of brivanib in subjects with advanced/metastatic solid tumors and (2) assess the safety and preliminary efficacy of single and multiple doses of brivanib alaninate in this population. METHODS: A two-part study was conducted consisting of a single-dose phase (Part A) and a multiple-dose phase (Part B). In Part A, subjects received a single dose of brivanib alaninate (800 mg) either in a fasting state or following ingestion of a high-fat meal (approximately 951 kcal [15% protein, 33% carbohydrate, 52% fat]); serial blood samples were collected for pharmacokinetic analysis up to 48 h post-dosing. In Part B, subjects received brivanib alaninate (800 mg) once daily until discontinuation. Throughout both phases, subjects were evaluated for adverse events (AEs) and best clinical response. RESULTS: No clinically significant differences in brivanib exposure were observed between fed and fasting subjects in Part A; C (max) was unchanged and AUC(INF) decreased marginally when administered in a fed versus fasted state. In Part A, the incidence of treatment-emergent AEs was broadly similar in a fed or fasted state. Brivanib alaninate was generally well tolerated throughout the study and showed preliminary evidence of antitumor activity. CONCLUSIONS: Consumption of a high-fat meal had no significant effect on brivanib pharmacokinetics. The study further demonstrates the acceptable safety/tolerability profile and antitumor potential of brivanib in patients with advanced malignancies. More... »

PAGES

1377-1385

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-011-1603-2

DOI

http://dx.doi.org/10.1007/s00280-011-1603-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1017984841

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21461891


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": "Alanine", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Antineoplastic Agents", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Cross-Over Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Female", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Food", 
        "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": "Middle Aged", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Neoplasm Metastasis", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Neoplasms", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Triazines", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Wayne State University", 
          "id": "https://www.grid.ac/institutes/grid.254444.7", 
          "name": [
            "Karmanos Cancer Institute, 4100 John R, 48201, Detroit, MI, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "LoRusso", 
        "givenName": "Patricia", 
        "id": "sg:person.012616064757.23", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012616064757.23"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Dana\u2013Farber Cancer Institute", 
          "id": "https://www.grid.ac/institutes/grid.65499.37", 
          "name": [
            "Dana Farber Cancer Institute, 44 Binney Street, 02115, Boston, MA, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Shapiro", 
        "givenName": "Geoffrey I.", 
        "id": "sg:person.0752005421.01", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0752005421.01"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Duke University Hospital", 
          "id": "https://www.grid.ac/institutes/grid.189509.c", 
          "name": [
            "Duke University Medical Center, DUMC 3052, 27710, Durham, NC, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hurwitz", 
        "givenName": "Herbert", 
        "id": "sg:person.01242177577.68", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01242177577.68"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Wayne State University", 
          "id": "https://www.grid.ac/institutes/grid.254444.7", 
          "name": [
            "Karmanos Cancer Institute, 4100 John R, 48201, Detroit, MI, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Pilat", 
        "givenName": "Mary Jo", 
        "id": "sg:person.01236150777.95", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01236150777.95"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Bristol-Myers Squibb (United States)", 
          "id": "https://www.grid.ac/institutes/grid.419971.3", 
          "name": [
            "Bristol-Myers Squibb, Route 206 & Province Line Road, 08540, Lawrenceville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Chemidlin", 
        "givenName": "Janice", 
        "id": "sg:person.01036173754.96", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01036173754.96"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Bristol-Myers Squibb (United States)", 
          "id": "https://www.grid.ac/institutes/grid.419971.3", 
          "name": [
            "Bristol-Myers Squibb, Route 206 & Province Line Road, 08540, Lawrenceville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Kollia", 
        "givenName": "Georgia", 
        "id": "sg:person.01150205302.12", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01150205302.12"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Bristol-Myers Squibb (United States)", 
          "id": "https://www.grid.ac/institutes/grid.419971.3", 
          "name": [
            "Bristol-Myers Squibb, Route 206 & Province Line Road, 08540, Lawrenceville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Syed", 
        "givenName": "Shariq", 
        "id": "sg:person.01334614301.44", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01334614301.44"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Bristol-Myers Squibb (United States)", 
          "id": "https://www.grid.ac/institutes/grid.419971.3", 
          "name": [
            "Bristol-Myers Squibb, Route 206 & Province Line Road, 08540, Lawrenceville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Fischer", 
        "givenName": "Bruce", 
        "id": "sg:person.01306467014.27", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01306467014.27"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Bristol-Myers Squibb (United States)", 
          "id": "https://www.grid.ac/institutes/grid.419971.3", 
          "name": [
            "Bristol-Myers Squibb, Route 206 & Province Line Road, 08540, Lawrenceville, NJ, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Masson", 
        "givenName": "Eric", 
        "id": "sg:person.014363567577.38", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014363567577.38"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "https://doi.org/10.1158/1078-0432.ccr-06-1249", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1002729921"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmoa061884", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1008302687"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1365-2133.2009.09290.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1016056620"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1111/j.1365-2133.2009.09290.x", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1016056620"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2009.22.3875", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1017142861"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/s1470-2045(08)70285-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1018829845"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/nrc2403", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1020862106", 
          "https://doi.org/10.1038/nrc2403"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1158/1535-7163.mct-09-0472", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1021242839"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmra0706596", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1021959499"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1158/1078-0432.ccr-08-0509", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1022697644"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/annonc/mdq599", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024792638"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmoa060655", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1025111240"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2009.27.2757", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1030212761"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1093/annonc/mdp533", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1030500263"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/cad.0b013e3283161012", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1030587655"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/cad.0b013e3283161012", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1030587655"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2005.02.2574", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1035170611"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2008.20.9908", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1042277532"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1124/dmd.110.033951", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1043803559"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1001/jama.2008.656", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1048505634"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3109/02841860903524396", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1053376167"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1056/nejmoa0708857", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1053513212"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1021/jm051106d", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1055949982"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1021/jm051106d", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1055949982"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1200/jco.2008.26.15_suppl.4111", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1079374834"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2011-12", 
    "datePublishedReg": "2011-12-01", 
    "description": "PURPOSE: Brivanib alaninate, an orally available prodrug of brivanib, is currently under evaluation for the treatment of several malignancies. This study aimed to (1) investigate effects of a high-fat meal on single-dose pharmacokinetics of brivanib in subjects with advanced/metastatic solid tumors and (2) assess the safety and preliminary efficacy of single and multiple doses of brivanib alaninate in this population.\nMETHODS: A two-part study was conducted consisting of a single-dose phase (Part A) and a multiple-dose phase (Part B). In Part A, subjects received a single dose of brivanib alaninate (800 mg) either in a fasting state or following ingestion of a high-fat meal (approximately 951 kcal [15% protein, 33% carbohydrate, 52% fat]); serial blood samples were collected for pharmacokinetic analysis up to 48 h post-dosing. In Part B, subjects received brivanib alaninate (800 mg) once daily until discontinuation. Throughout both phases, subjects were evaluated for adverse events (AEs) and best clinical response.\nRESULTS: No clinically significant differences in brivanib exposure were observed between fed and fasting subjects in Part A; C (max) was unchanged and AUC(INF) decreased marginally when administered in a fed versus fasted state. In Part A, the incidence of treatment-emergent AEs was broadly similar in a fed or fasted state. Brivanib alaninate was generally well tolerated throughout the study and showed preliminary evidence of antitumor activity.\nCONCLUSIONS: Consumption of a high-fat meal had no significant effect on brivanib pharmacokinetics. The study further demonstrates the acceptable safety/tolerability profile and antitumor potential of brivanib in patients with advanced malignancies.", 
    "genre": "research_article", 
    "id": "sg:pub.10.1007/s00280-011-1603-2", 
    "inLanguage": [
      "en"
    ], 
    "isAccessibleForFree": false, 
    "isPartOf": [
      {
        "id": "sg:journal.1088364", 
        "issn": [
          "0344-5704", 
          "1432-0843"
        ], 
        "name": "Cancer Chemotherapy and Pharmacology", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "6", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "68"
      }
    ], 
    "name": "Lack of food effect on single-dose pharmacokinetics of brivanib, and safety and efficacy following multiple doses in subjects with advanced or metastatic solid tumors", 
    "pagination": "1377-1385", 
    "productId": [
      {
        "name": "readcube_id", 
        "type": "PropertyValue", 
        "value": [
          "55b0e5524e8023b82e4fb82b2cc684d034240dfec6b7e9223af363f58dff3c3a"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "21461891"
        ]
      }, 
      {
        "name": "nlm_unique_id", 
        "type": "PropertyValue", 
        "value": [
          "7806519"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1007/s00280-011-1603-2"
        ]
      }, 
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1017984841"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1007/s00280-011-1603-2", 
      "https://app.dimensions.ai/details/publication/pub.1017984841"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2019-04-11T00:16", 
    "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/v90/0000000001_0000000264/records_8695_00000512.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "http://link.springer.com/10.1007%2Fs00280-011-1603-2"
  }
]
 

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/s00280-011-1603-2'

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/s00280-011-1603-2'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s00280-011-1603-2'

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

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s00280-011-1603-2'


 

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

257 TRIPLES      21 PREDICATES      65 URIs      35 LITERALS      23 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1007/s00280-011-1603-2 schema:about N116cc999794e4301ae40d88e5f2825b0
2 N149a75332b92408d880e7854322d1206
3 N203e56c055624fefab299a59786d4a09
4 N3b8455d1574a483081c5a00c3a252054
5 N42d0be51804645c3936a28ae4d7a4abf
6 N7424fbf7ad1d4bf6a09b5da89e9589a8
7 N74b8bf38ecc144dbbc6e55c6267ceb69
8 Nb1a34760c02c4f51bce69a2e8858ae12
9 Nb27e1d3e0d134d9296e4c8082a5c7e21
10 Nb693e3c2752344db9d08883250ff906b
11 Nd9be0c3d13a4437182cef06923b853e2
12 Nf84a79aa9563416a8a2f300561671398
13 Nf9ba732603474e6b9a4289537dd64c99
14 Nfbde03ce3e754491aaceb2361245cae5
15 anzsrc-for:11
16 anzsrc-for:1103
17 schema:author Nb5b5107311c64616abc7ecfbdc8e5658
18 schema:citation sg:pub.10.1038/nrc2403
19 https://doi.org/10.1001/jama.2008.656
20 https://doi.org/10.1016/s1470-2045(08)70285-7
21 https://doi.org/10.1021/jm051106d
22 https://doi.org/10.1056/nejmoa060655
23 https://doi.org/10.1056/nejmoa061884
24 https://doi.org/10.1056/nejmoa0708857
25 https://doi.org/10.1056/nejmra0706596
26 https://doi.org/10.1093/annonc/mdp533
27 https://doi.org/10.1093/annonc/mdq599
28 https://doi.org/10.1097/cad.0b013e3283161012
29 https://doi.org/10.1111/j.1365-2133.2009.09290.x
30 https://doi.org/10.1124/dmd.110.033951
31 https://doi.org/10.1158/1078-0432.ccr-06-1249
32 https://doi.org/10.1158/1078-0432.ccr-08-0509
33 https://doi.org/10.1158/1535-7163.mct-09-0472
34 https://doi.org/10.1200/jco.2005.02.2574
35 https://doi.org/10.1200/jco.2008.20.9908
36 https://doi.org/10.1200/jco.2008.26.15_suppl.4111
37 https://doi.org/10.1200/jco.2009.22.3875
38 https://doi.org/10.1200/jco.2009.27.2757
39 https://doi.org/10.3109/02841860903524396
40 schema:datePublished 2011-12
41 schema:datePublishedReg 2011-12-01
42 schema:description PURPOSE: Brivanib alaninate, an orally available prodrug of brivanib, is currently under evaluation for the treatment of several malignancies. This study aimed to (1) investigate effects of a high-fat meal on single-dose pharmacokinetics of brivanib in subjects with advanced/metastatic solid tumors and (2) assess the safety and preliminary efficacy of single and multiple doses of brivanib alaninate in this population. METHODS: A two-part study was conducted consisting of a single-dose phase (Part A) and a multiple-dose phase (Part B). In Part A, subjects received a single dose of brivanib alaninate (800 mg) either in a fasting state or following ingestion of a high-fat meal (approximately 951 kcal [15% protein, 33% carbohydrate, 52% fat]); serial blood samples were collected for pharmacokinetic analysis up to 48 h post-dosing. In Part B, subjects received brivanib alaninate (800 mg) once daily until discontinuation. Throughout both phases, subjects were evaluated for adverse events (AEs) and best clinical response. RESULTS: No clinically significant differences in brivanib exposure were observed between fed and fasting subjects in Part A; C (max) was unchanged and AUC(INF) decreased marginally when administered in a fed versus fasted state. In Part A, the incidence of treatment-emergent AEs was broadly similar in a fed or fasted state. Brivanib alaninate was generally well tolerated throughout the study and showed preliminary evidence of antitumor activity. CONCLUSIONS: Consumption of a high-fat meal had no significant effect on brivanib pharmacokinetics. The study further demonstrates the acceptable safety/tolerability profile and antitumor potential of brivanib in patients with advanced malignancies.
43 schema:genre research_article
44 schema:inLanguage en
45 schema:isAccessibleForFree false
46 schema:isPartOf Ne1c1af8e4df44f8aab6c0d21ef6ef766
47 Nee21a1c890bf4e5b8dbfe800da4df048
48 sg:journal.1088364
49 schema:name Lack of food effect on single-dose pharmacokinetics of brivanib, and safety and efficacy following multiple doses in subjects with advanced or metastatic solid tumors
50 schema:pagination 1377-1385
51 schema:productId N10f8444bee4548ca9a832ec472bd6076
52 N572a6b42ae2948b19479701721012ae3
53 N79a9d34e15d5489aa37e0907acb44cb9
54 Na6cb5e4117344cf281422f9eae78f1d8
55 Naef986582f2345a482f8e00f07d80a0c
56 schema:sameAs https://app.dimensions.ai/details/publication/pub.1017984841
57 https://doi.org/10.1007/s00280-011-1603-2
58 schema:sdDatePublished 2019-04-11T00:16
59 schema:sdLicense https://scigraph.springernature.com/explorer/license/
60 schema:sdPublisher N9cb6bd1e8e084ef99cc0eb68fc37df54
61 schema:url http://link.springer.com/10.1007%2Fs00280-011-1603-2
62 sgo:license sg:explorer/license/
63 sgo:sdDataset articles
64 rdf:type schema:ScholarlyArticle
65 N10f8444bee4548ca9a832ec472bd6076 schema:name dimensions_id
66 schema:value pub.1017984841
67 rdf:type schema:PropertyValue
68 N116cc999794e4301ae40d88e5f2825b0 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
69 schema:name Alanine
70 rdf:type schema:DefinedTerm
71 N149a75332b92408d880e7854322d1206 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
72 schema:name Aged, 80 and over
73 rdf:type schema:DefinedTerm
74 N203e56c055624fefab299a59786d4a09 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
75 schema:name Aged
76 rdf:type schema:DefinedTerm
77 N274e2f48968f4bbf8a7669485ba75cd4 rdf:first sg:person.01242177577.68
78 rdf:rest N9479b1065a404d82b64a20070ddcd9ee
79 N2856e593e393490799fedce50e001779 rdf:first sg:person.01334614301.44
80 rdf:rest N3b60e3f7251a429daddf6603dabaab0b
81 N39b3028ee9274cd18c111fcfd86cb72f rdf:first sg:person.01150205302.12
82 rdf:rest N2856e593e393490799fedce50e001779
83 N3b60e3f7251a429daddf6603dabaab0b rdf:first sg:person.01306467014.27
84 rdf:rest N7aadf3d2dc824ebb8383e00633764313
85 N3b8455d1574a483081c5a00c3a252054 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
86 schema:name Neoplasms
87 rdf:type schema:DefinedTerm
88 N42d0be51804645c3936a28ae4d7a4abf schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
89 schema:name Neoplasm Metastasis
90 rdf:type schema:DefinedTerm
91 N572a6b42ae2948b19479701721012ae3 schema:name doi
92 schema:value 10.1007/s00280-011-1603-2
93 rdf:type schema:PropertyValue
94 N7424fbf7ad1d4bf6a09b5da89e9589a8 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
95 schema:name Cross-Over Studies
96 rdf:type schema:DefinedTerm
97 N74b8bf38ecc144dbbc6e55c6267ceb69 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
98 schema:name Middle Aged
99 rdf:type schema:DefinedTerm
100 N79a9d34e15d5489aa37e0907acb44cb9 schema:name readcube_id
101 schema:value 55b0e5524e8023b82e4fb82b2cc684d034240dfec6b7e9223af363f58dff3c3a
102 rdf:type schema:PropertyValue
103 N7aadf3d2dc824ebb8383e00633764313 rdf:first sg:person.014363567577.38
104 rdf:rest rdf:nil
105 N9479b1065a404d82b64a20070ddcd9ee rdf:first sg:person.01236150777.95
106 rdf:rest N9e7a7151ae944677bcea17cba79db0fb
107 N9cb6bd1e8e084ef99cc0eb68fc37df54 schema:name Springer Nature - SN SciGraph project
108 rdf:type schema:Organization
109 N9e7a7151ae944677bcea17cba79db0fb rdf:first sg:person.01036173754.96
110 rdf:rest N39b3028ee9274cd18c111fcfd86cb72f
111 Na6cb5e4117344cf281422f9eae78f1d8 schema:name pubmed_id
112 schema:value 21461891
113 rdf:type schema:PropertyValue
114 Naef986582f2345a482f8e00f07d80a0c schema:name nlm_unique_id
115 schema:value 7806519
116 rdf:type schema:PropertyValue
117 Nb1a34760c02c4f51bce69a2e8858ae12 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
118 schema:name Antineoplastic Agents
119 rdf:type schema:DefinedTerm
120 Nb27e1d3e0d134d9296e4c8082a5c7e21 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
121 schema:name Food
122 rdf:type schema:DefinedTerm
123 Nb5b5107311c64616abc7ecfbdc8e5658 rdf:first sg:person.012616064757.23
124 rdf:rest Nd0f4b24b67b34b42b312f2f9dd537ccc
125 Nb693e3c2752344db9d08883250ff906b schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
126 schema:name Female
127 rdf:type schema:DefinedTerm
128 Nd0f4b24b67b34b42b312f2f9dd537ccc rdf:first sg:person.0752005421.01
129 rdf:rest N274e2f48968f4bbf8a7669485ba75cd4
130 Nd9be0c3d13a4437182cef06923b853e2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
131 schema:name Humans
132 rdf:type schema:DefinedTerm
133 Ne1c1af8e4df44f8aab6c0d21ef6ef766 schema:volumeNumber 68
134 rdf:type schema:PublicationVolume
135 Nee21a1c890bf4e5b8dbfe800da4df048 schema:issueNumber 6
136 rdf:type schema:PublicationIssue
137 Nf84a79aa9563416a8a2f300561671398 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
138 schema:name Adult
139 rdf:type schema:DefinedTerm
140 Nf9ba732603474e6b9a4289537dd64c99 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
141 schema:name Male
142 rdf:type schema:DefinedTerm
143 Nfbde03ce3e754491aaceb2361245cae5 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
144 schema:name Triazines
145 rdf:type schema:DefinedTerm
146 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
147 schema:name Medical and Health Sciences
148 rdf:type schema:DefinedTerm
149 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
150 schema:name Clinical Sciences
151 rdf:type schema:DefinedTerm
152 sg:journal.1088364 schema:issn 0344-5704
153 1432-0843
154 schema:name Cancer Chemotherapy and Pharmacology
155 rdf:type schema:Periodical
156 sg:person.01036173754.96 schema:affiliation https://www.grid.ac/institutes/grid.419971.3
157 schema:familyName Chemidlin
158 schema:givenName Janice
159 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01036173754.96
160 rdf:type schema:Person
161 sg:person.01150205302.12 schema:affiliation https://www.grid.ac/institutes/grid.419971.3
162 schema:familyName Kollia
163 schema:givenName Georgia
164 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01150205302.12
165 rdf:type schema:Person
166 sg:person.01236150777.95 schema:affiliation https://www.grid.ac/institutes/grid.254444.7
167 schema:familyName Pilat
168 schema:givenName Mary Jo
169 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01236150777.95
170 rdf:type schema:Person
171 sg:person.01242177577.68 schema:affiliation https://www.grid.ac/institutes/grid.189509.c
172 schema:familyName Hurwitz
173 schema:givenName Herbert
174 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01242177577.68
175 rdf:type schema:Person
176 sg:person.012616064757.23 schema:affiliation https://www.grid.ac/institutes/grid.254444.7
177 schema:familyName LoRusso
178 schema:givenName Patricia
179 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012616064757.23
180 rdf:type schema:Person
181 sg:person.01306467014.27 schema:affiliation https://www.grid.ac/institutes/grid.419971.3
182 schema:familyName Fischer
183 schema:givenName Bruce
184 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01306467014.27
185 rdf:type schema:Person
186 sg:person.01334614301.44 schema:affiliation https://www.grid.ac/institutes/grid.419971.3
187 schema:familyName Syed
188 schema:givenName Shariq
189 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01334614301.44
190 rdf:type schema:Person
191 sg:person.014363567577.38 schema:affiliation https://www.grid.ac/institutes/grid.419971.3
192 schema:familyName Masson
193 schema:givenName Eric
194 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014363567577.38
195 rdf:type schema:Person
196 sg:person.0752005421.01 schema:affiliation https://www.grid.ac/institutes/grid.65499.37
197 schema:familyName Shapiro
198 schema:givenName Geoffrey I.
199 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0752005421.01
200 rdf:type schema:Person
201 sg:pub.10.1038/nrc2403 schema:sameAs https://app.dimensions.ai/details/publication/pub.1020862106
202 https://doi.org/10.1038/nrc2403
203 rdf:type schema:CreativeWork
204 https://doi.org/10.1001/jama.2008.656 schema:sameAs https://app.dimensions.ai/details/publication/pub.1048505634
205 rdf:type schema:CreativeWork
206 https://doi.org/10.1016/s1470-2045(08)70285-7 schema:sameAs https://app.dimensions.ai/details/publication/pub.1018829845
207 rdf:type schema:CreativeWork
208 https://doi.org/10.1021/jm051106d schema:sameAs https://app.dimensions.ai/details/publication/pub.1055949982
209 rdf:type schema:CreativeWork
210 https://doi.org/10.1056/nejmoa060655 schema:sameAs https://app.dimensions.ai/details/publication/pub.1025111240
211 rdf:type schema:CreativeWork
212 https://doi.org/10.1056/nejmoa061884 schema:sameAs https://app.dimensions.ai/details/publication/pub.1008302687
213 rdf:type schema:CreativeWork
214 https://doi.org/10.1056/nejmoa0708857 schema:sameAs https://app.dimensions.ai/details/publication/pub.1053513212
215 rdf:type schema:CreativeWork
216 https://doi.org/10.1056/nejmra0706596 schema:sameAs https://app.dimensions.ai/details/publication/pub.1021959499
217 rdf:type schema:CreativeWork
218 https://doi.org/10.1093/annonc/mdp533 schema:sameAs https://app.dimensions.ai/details/publication/pub.1030500263
219 rdf:type schema:CreativeWork
220 https://doi.org/10.1093/annonc/mdq599 schema:sameAs https://app.dimensions.ai/details/publication/pub.1024792638
221 rdf:type schema:CreativeWork
222 https://doi.org/10.1097/cad.0b013e3283161012 schema:sameAs https://app.dimensions.ai/details/publication/pub.1030587655
223 rdf:type schema:CreativeWork
224 https://doi.org/10.1111/j.1365-2133.2009.09290.x schema:sameAs https://app.dimensions.ai/details/publication/pub.1016056620
225 rdf:type schema:CreativeWork
226 https://doi.org/10.1124/dmd.110.033951 schema:sameAs https://app.dimensions.ai/details/publication/pub.1043803559
227 rdf:type schema:CreativeWork
228 https://doi.org/10.1158/1078-0432.ccr-06-1249 schema:sameAs https://app.dimensions.ai/details/publication/pub.1002729921
229 rdf:type schema:CreativeWork
230 https://doi.org/10.1158/1078-0432.ccr-08-0509 schema:sameAs https://app.dimensions.ai/details/publication/pub.1022697644
231 rdf:type schema:CreativeWork
232 https://doi.org/10.1158/1535-7163.mct-09-0472 schema:sameAs https://app.dimensions.ai/details/publication/pub.1021242839
233 rdf:type schema:CreativeWork
234 https://doi.org/10.1200/jco.2005.02.2574 schema:sameAs https://app.dimensions.ai/details/publication/pub.1035170611
235 rdf:type schema:CreativeWork
236 https://doi.org/10.1200/jco.2008.20.9908 schema:sameAs https://app.dimensions.ai/details/publication/pub.1042277532
237 rdf:type schema:CreativeWork
238 https://doi.org/10.1200/jco.2008.26.15_suppl.4111 schema:sameAs https://app.dimensions.ai/details/publication/pub.1079374834
239 rdf:type schema:CreativeWork
240 https://doi.org/10.1200/jco.2009.22.3875 schema:sameAs https://app.dimensions.ai/details/publication/pub.1017142861
241 rdf:type schema:CreativeWork
242 https://doi.org/10.1200/jco.2009.27.2757 schema:sameAs https://app.dimensions.ai/details/publication/pub.1030212761
243 rdf:type schema:CreativeWork
244 https://doi.org/10.3109/02841860903524396 schema:sameAs https://app.dimensions.ai/details/publication/pub.1053376167
245 rdf:type schema:CreativeWork
246 https://www.grid.ac/institutes/grid.189509.c schema:alternateName Duke University Hospital
247 schema:name Duke University Medical Center, DUMC 3052, 27710, Durham, NC, USA
248 rdf:type schema:Organization
249 https://www.grid.ac/institutes/grid.254444.7 schema:alternateName Wayne State University
250 schema:name Karmanos Cancer Institute, 4100 John R, 48201, Detroit, MI, USA
251 rdf:type schema:Organization
252 https://www.grid.ac/institutes/grid.419971.3 schema:alternateName Bristol-Myers Squibb (United States)
253 schema:name Bristol-Myers Squibb, Route 206 & Province Line Road, 08540, Lawrenceville, NJ, USA
254 rdf:type schema:Organization
255 https://www.grid.ac/institutes/grid.65499.37 schema:alternateName Dana–Farber Cancer Institute
256 schema:name Dana Farber Cancer Institute, 44 Binney Street, 02115, Boston, MA, USA
257 rdf:type schema:Organization
 




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


...