dc.contributor.author | Evans, TRJ | |
dc.contributor.author | Dean, E | |
dc.contributor.author | Molife, LR | |
dc.contributor.author | Lopez, J | |
dc.contributor.author | Ranson, M | |
dc.contributor.author | El-Khouly, F | |
dc.contributor.author | Zubairi, I | |
dc.contributor.author | Savulsky, C | |
dc.contributor.author | Reyderman, L | |
dc.contributor.author | Jia, Y | |
dc.contributor.author | Sweeting, L | |
dc.contributor.author | Greystoke, A | |
dc.contributor.author | Barriuso, J | |
dc.contributor.author | Kristeleit, R | |
dc.date.accessioned | 2020-04-28T10:38:14Z | |
dc.date.issued | 2019-02 | |
dc.identifier.citation | British journal of cancer, 2019, 120 (4), pp. 379 - 386 | |
dc.identifier.issn | 0007-0920 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3601 | |
dc.identifier.eissn | 1532-1827 | |
dc.identifier.doi | 10.1038/s41416-019-0377-x | |
dc.description.abstract | BACKGROUND: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. | |
dc.format | Print-Electronic | |
dc.format.extent | 379 - 386 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Neoplasms | |
dc.subject | Ketones | |
dc.subject | Furans | |
dc.subject | Liposomes | |
dc.subject | Drug Compounding | |
dc.subject | Maximum Tolerated Dose | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.title | Phase 1 dose-finding and pharmacokinetic study of eribulin-liposomal formulation in patients with solid tumours. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2019-01-03 | |
rioxxterms.versionofrecord | 10.1038/s41416-019-0377-x | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-02 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | British journal of cancer | |
pubs.issue | 4 | |
pubs.notes | Not known | |
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.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-status | Published | |
pubs.volume | 120 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Medicine (de Bono Prostate) | |
dc.contributor.icrauthor | Lopez, Juanita | |