Phase IV clinical trial - Pédiatrie Tumeurs solides

Pédiatrie Tumeurs solides
Ouvert depuis le: 03.02.2024
Site: Paris
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An open label, multi-center roll-over study to assess longterm;effect in pediatric patients treated with Tafinlar;(dabrafenib) and/or Mekinist (trametinib)
Description de l'essai
This study will facilitate data collection of the long-term outcomes of pediatric;subjects who have been treated in clinical trials with dabrafenib, trametinib or the;combination, to assess the long-term effect on growth, development and general;health of these subjects. Further, for those subjects currently on treatment in the;parent protocol and would benefit from continued treatment (per investigator;determination), this study will offer a mechanism to continue treatment outside the;parent protocols.;This is a global single-arm, open-label, multi-center study to collect data on the;long-term effects of dabrafenib, trametinib or the combination in pediatric subjects;who have been treated on Novartis sponsored trials. No formal hypothesis will be;tested. Additionally, this study will provide continued access to study medication(s);for subjects who have previously participated in dabrafenib and/or trametinib;treatment studies (parent studies).;Parent studies include:;? CDRB436A2102:;Phase I/IIa, 2-part, multi-center, single-arm, open-label study to determine the;safety, tolerability and pharmacokinetics of oral dabrafenib in children and;adolescent patients with advanced BRAF V600-mutation positive solid tumors.;? CTMT212X2101:;Pharmacodynamics and clinical activity of the MEK inhibitor trametinib in;children and adolescents patients with cancer or plexiform neurofibromas and;trametinib in combination with dabrafenib in children and adolescents with;cancers harboring V600 mutation.;? CDRB436G2201:;Phase II open-label global study to evaluate the effect of dabrafenib in;combination with trametinib in children and adolescent patients with BRAF;V600-mutation positive Low Grade Glioma (LGG) or relapsed or refractory;High Grade Glioma (HGG).
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