Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 Nov 2022

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Brain cancer; Cancer; Ewing's sarcoma; Glioma; Langerhans cell histiocytosis; Liver cancer; Neuroblastoma; Neurofibromatosis 1; Osteosarcoma; Plexiform neurofibroma; Rhabdomyosarcoma; Soft tissue sarcoma; Solid tumours; Wilms' tumour
  • Focus Adverse reactions; Registrational
  • Sponsors GlaxoSmithKline; GSK; Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 14 Nov 2022 Results assessing Efficacy and Safety of Trametinib Monotherapy or in Combination With Dabrafenib in Pediatric BRAF V600-Mutant Low-Grade Glioma published in the Journal of Clinical Oncology
  • 22 Jun 2022 According to a Novartis media release, the US Food and Drug Administration (FDA) granted accelerated approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
  • 14 Dec 2021 Results of pooled analysis of patients with LCH from two open-label phase I/II studies in pediatric pts with recurrent/refractory malignancies, treated with dabrafenib monotherapy (CDRB436A2102; NCT01677741) or dabrafenib plus trametinib (CTMT212X2101; NCT02124772) presented at the 63rd American Society of Hematology Annual Meeting and Exposition

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top