Show simple item record

dc.contributor.authorMoreno, L
dc.contributor.authorPearson, ADJ
dc.contributor.authorPaoletti, X
dc.contributor.authorJimenez, I
dc.contributor.authorGeoerger, B
dc.contributor.authorKearns, PR
dc.contributor.authorZwaan, CM
dc.contributor.authorDoz, F
dc.contributor.authorBaruchel, A
dc.contributor.authorVormoor, J
dc.contributor.authorCasanova, M
dc.contributor.authorPfister, SM
dc.contributor.authorMorland, B
dc.contributor.authorVassal, G
dc.contributor.authorInnovative Therapies for Children with Cancer (ITCC) Consortium
dc.date.accessioned2018-08-03T09:25:09Z
dc.date.issued2017-08
dc.identifier.citationNature reviews. Clinical oncology, 2017, 14 (8), pp. 497 - 507
dc.identifier.issn1759-4774
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2249
dc.identifier.eissn1759-4782
dc.identifier.doi10.1038/nrclinonc.2017.59
dc.description.abstractIn the past decade, the landscape of drug development in oncology has evolved dramatically; however, this paradigm shift remains to be adopted in early phase clinical trial designs for studies of molecularly targeted agents and immunotherapeutic agents in paediatric malignancies. In drug development, prioritization of drugs on the basis of knowledge of tumour biology, molecular 'drivers' of disease and a drug's mechanism of action, and therapeutic unmet needs are key elements; these aspects are relevant to early phase paediatric trials, in which molecular profiling is strongly encouraged. Herein, we describe the strategy of the Innovative Therapies for Children with Cancer (ITCC) Consortium, which advocates for the adoption of trial designs that enable uninterrupted patient recruitment, the extrapolation from studies in adults when possible, and the inclusion of expansion cohorts. If a drug has neither serious dose-related toxicities nor a narrow therapeutic index, then studies should generally be started at the adult recommended phase II dose corrected for body surface area, and act as dose-confirmation studies. The use of adaptive trial designs will enable drugs with promising activity to progress rapidly to randomized studies and, therefore, will substantially accelerate drug development for children and adolescents with cancer.
dc.formatPrint-Electronic
dc.format.extent497 - 507
dc.languageeng
dc.language.isoeng
dc.subjectInnovative Therapies for Children with Cancer (ITCC) Consortium
dc.subjectHumans
dc.subjectNeoplasms
dc.subjectAntineoplastic Agents
dc.subjectAdolescent
dc.subjectChild
dc.subjectAdolescent Health Services
dc.subjectChild Health Services
dc.subjectSocieties, Medical
dc.subjectEurope
dc.subjectClinical Trials as Topic
dc.titleEarly phase clinical trials of anticancer agents in children and adolescents - an ITCC perspective.
dc.typeJournal Article
rioxxterms.versionofrecord10.1038/nrclinonc.2017.59
rioxxterms.licenseref.startdate2017-08
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfNature reviews. Clinical oncology
pubs.issue8
pubs.notesNot 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/Paediatric Drug Development and Clinical Trials
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Paediatric Drug Development and Clinical Trials
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams/Paediatric Drug Development and Clinical Trials
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/Paediatric Drug Development and Clinical Trials
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Paediatric Drug Development and Clinical Trials
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams/Paediatric Drug Development and Clinical Trials
pubs.publication-statusPublished
pubs.volume14
pubs.embargo.termsNot known
icr.researchteamPaediatric Drug Development and Clinical Trialsen_US
dc.contributor.icrauthorPearson, Andrewen


Files in this item

FilesSizeFormatView

There are no files associated with this item.

This item appears in the following collection(s)

Show simple item record