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: 30 Sep 2017

At a glance

  • Drugs Trametinib (Primary) ; Dabrafenib
  • Indications Plexiform neurofibroma
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline; Novartis; Novartis Pharma A.G.
  • Most Recent Events

    • 20 Jul 2017 Planned End Date changed from 15 Apr 2020 to 15 Oct 2020.
    • 20 Jul 2017 Planned primary completion date changed from 15 Apr 2020 to 15 Oct 2020.
    • 03 Jul 2017 Number of arms has changed from 3 to 4,Part D has also added to the study,hence patient number has also increased from 94 t0 142
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