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000125391 0247_ $$2doi$$a10.1038/nrclinonc.2017.59
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000125391 0247_ $$2ISSN$$a1759-4774
000125391 0247_ $$2ISSN$$a1759-4782
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000125391 041__ $$aeng
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000125391 1001_ $$aMoreno, Lucas$$b0
000125391 245__ $$aEarly phase clinical trials of anticancer agents in children and adolescents - an ITCC perspective.
000125391 260__ $$aNew York, NY$$bNature Publ. Group$$c2017
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000125391 520__ $$aIn 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.
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000125391 650_7 $$2NLM Chemicals$$aAntineoplastic Agents
000125391 7001_ $$aPearson, Andrew D J$$b1
000125391 7001_ $$aPaoletti, Xavier$$b2
000125391 7001_ $$aJimenez, Irene$$b3
000125391 7001_ $$aGeoerger, Birgit$$b4
000125391 7001_ $$aKearns, Pamela R$$b5
000125391 7001_ $$aZwaan, C Michel$$b6
000125391 7001_ $$aDoz, Francois$$b7
000125391 7001_ $$aBaruchel, Andre$$b8
000125391 7001_ $$aVormoor, Josef$$b9
000125391 7001_ $$aCasanova, Michela$$b10
000125391 7001_ $$0P:(DE-He78)f746aa965c4e1af518b016de3aaff5d9$$aPfister, Stefan$$b11$$udkfz
000125391 7001_ $$aMorland, Bruce$$b12
000125391 7001_ $$aVassal, Gilles$$b13
000125391 7001_ $$aCancer, Innovative Therapies for Children with$$b14$$eCollaboration Author
000125391 773__ $$0PERI:(DE-600)2491414-9$$a10.1038/nrclinonc.2017.59$$gVol. 14, no. 8, p. 497 - 507$$n8$$p497 - 507$$tNature reviews / Clinical oncology$$v14$$x1759-4782$$y2017
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