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dc.contributor.authorEvans, TRJen_US
dc.contributor.authorDean, Een_US
dc.contributor.authorMolife, LRen_US
dc.contributor.authorLopez, Jen_US
dc.contributor.authorRanson, Men_US
dc.contributor.authorEl-Khouly, Fen_US
dc.contributor.authorZubairi, Ien_US
dc.contributor.authorSavulsky, Cen_US
dc.contributor.authorReyderman, Len_US
dc.contributor.authorJia, Yen_US
dc.contributor.authorSweeting, Len_US
dc.contributor.authorGreystoke, Aen_US
dc.contributor.authorBarriuso, Jen_US
dc.contributor.authorKristeleit, Ren_US
dc.date.accessioned2020-04-28T10:38:14Z
dc.date.issued2019-02en_US
dc.identifier.citationBritish journal of cancer, 2019, 120 (4), pp. 379 - 386en_US
dc.identifier.issn0007-0920en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3601
dc.identifier.eissn1532-1827en_US
dc.identifier.doi10.1038/s41416-019-0377-xen_US
dc.description.abstractBACKGROUND:This phase 1 study examined the safety, tolerability, pharmacokinetics and preliminary efficacy of eribulin-liposomal formulation (eribulin-LF) in patients with advanced solid tumours. METHODS:Eligible patients with ECOG PS 0-1 were treated with eribulin-LF either on day 1 every 21 days (Schedule 1), or on days 1 and 15 every 28 days (Schedule 2). Doses ranged from 1.0 to 3.5 mg/m2, with dose escalation in a 3 + 3 design. The dose-expansion phase evaluated eribulin-LF in select tumour types. PRIMARY OBJECTIVES:maximum tolerated dose (MTD) and the recommended dose/schedule of eribulin-LF. RESULTS:Totally, 58 patients were enroled (median age = 62 years). The MTD was 1.4 mg/m2 (Schedule 1) or 1.5 mg/m2 (Schedule 2), the latter dose selected for the dose-expansion phase. Dose-limiting toxicity (DLTs) in Schedule 1: hypophosphatemia and increased transaminase levels. DLTs in Schedule 2: stomatitis, increased alanine aminotransferase, neutropenia and febrile neutropenia. The pharmacokinetic profile of eribulin-LF showed a similar half-life to that of eribulin (~30 h), but with a 5-fold greater maximum serum concentration and a 40-fold greater area-under-the-curve. Eribulin-LF demonstrated clinical activity with approximately 10% of patients in both schedules achieving partial responses. CONCLUSIONS:Eribulin-LF was well tolerated with a favourable pharmacokinetic profile. Preliminary evidence of clinical activity in solid tumours was observed.en_US
dc.formatPrint-Electronicen_US
dc.format.extent379 - 386en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.subjectHumansen_US
dc.subjectNeoplasmsen_US
dc.subjectKetonesen_US
dc.subjectFuransen_US
dc.subjectLiposomesen_US
dc.subjectDrug Compoundingen_US
dc.subjectMaximum Tolerated Doseen_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectMiddle Ageden_US
dc.subjectFemaleen_US
dc.subjectMaleen_US
dc.titlePhase 1 dose-finding and pharmacokinetic study of eribulin-liposomal formulation in patients with solid tumours.en_US
dc.typeJournal Article
dcterms.dateAccepted2019-01-03en_US
rioxxterms.versionofrecord10.1038/s41416-019-0377-xen_US
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0en_US
rioxxterms.licenseref.startdate2019-02en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfBritish journal of canceren_US
pubs.issue4en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics/Medicine (de Bono Prostate)
pubs.publication-statusPublisheden_US
pubs.volume120en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMedicine (de Bono Prostate)en_US
dc.contributor.icrauthorLopez, Juanitaen_US


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