% IMPORTANT: The following is UTF-8 encoded. This means that in the presence
% of non-ASCII characters, it will not work with BibTeX 0.99 or older.
% Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or
% “biber”.
@ARTICLE{Moreno:125391,
author = {L. Moreno and A. D. J. Pearson and X. Paoletti and I.
Jimenez and B. Geoerger and P. R. Kearns and C. M. Zwaan and
F. Doz and A. Baruchel and J. Vormoor and M. Casanova and S.
Pfister$^*$ and B. Morland and G. Vassal},
collaboration = {I. T. f. C. w. Cancer},
title = {{E}arly phase clinical trials of anticancer agents in
children and adolescents - an {ITCC} perspective.},
journal = {Nature reviews / Clinical oncology},
volume = {14},
number = {8},
issn = {1759-4782},
address = {New York, NY},
publisher = {Nature Publ. Group},
reportid = {DKFZ-2017-01521},
pages = {497 - 507},
year = {2017},
abstract = {In 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.},
subtyp = {Review Article},
keywords = {Antineoplastic Agents (NLM Chemicals)},
cin = {B062 / L101},
ddc = {610},
cid = {I:(DE-He78)B062-20160331 / I:(DE-He78)L101-20160331},
pnm = {312 - Functional and structural genomics (POF3-312)},
pid = {G:(DE-HGF)POF3-312},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:28508875},
doi = {10.1038/nrclinonc.2017.59},
url = {https://inrepo02.dkfz.de/record/125391},
}