An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Children and Adolescents With Cancers Harboring V600 Mutations

Trial Profile

An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Children and Adolescents With Cancers Harboring V600 Mutations

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Jun 2018

At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Brain cancer; Cancer; Ewing's sarcoma; Glioma; Langerhans cell histiocytosis; Liver cancer; Neuroblastoma; Osteosarcoma; Plexiform neurofibroma; Rhabdomyosarcoma; Soft tissue sarcoma; Solid tumours; Wilms' tumour
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline; Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals
  • Most Recent Events

    • 05 Jun 2018 Results of phase I (Part A (n=40) and Part C (n=12) assessing safety and pharmacokinetics of trametinib alone and in combination with dabrafenib in children and adolescents with relapsed solid tumors or neurofibromatosis type 1 progressive plexiform neurofibromas , presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
    • 05 Jun 2018 Results of an interim analysis from the disease-expansion cohort (n = 10) in patients with NF-1 associated Plexiform Neurofibromas, presented at the 54th Annual Meeting of the American Society of Clinical Oncology
    • 20 Jul 2017 Planned End Date changed from 15 Apr 2020 to 15 Oct 2020.
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