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@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},
}