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 Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors
Latest Information Update: 05 Sep 2023
At a glance
- Drugs Dabrafenib (Primary)
- Indications Glioma; Langerhans cell histiocytosis; Malignant melanoma; Solid tumours; Thyroid cancer
- Focus Adverse reactions; Pharmacokinetics
- Sponsors GlaxoSmithKline; GSK; Novartis; Novartis Pharmaceuticals
- 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
- 24 Dec 2020 Status changed from active, no longer recruiting to completed.
- 27 Jul 2020 This trial is completed in UK (Global End Date: 26 Apr 2016), according to European Clinical Trials Database record.