- •A new set of dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D) definitions have been issued for molecularly targeted agents' adult phase I trials.
- •We analysed the Innovative Therapies for Children with Cancer Consortium dose-finding trials and conducted a survey with among expert pediatricians.
- •Several proposals for adult dose-finding trials are translated in paediatric studies.
- •DLTs should be homogeneously defined across trials.
- •Definition of RP2D should include delayed toxicities and supported by pharmacokinetics/pharmacodynamics data.
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