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
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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
- 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