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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

Trial Profile

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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Jul 2019

At a glance

  • Drugs Dabrafenib (Primary)
  • Indications Glioma; Langerhans cell histiocytosis; Malignant melanoma; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors GlaxoSmithKline; Novartis
  • Most Recent Events

    • 30 Jun 2019 Trial has been completed in Denmark, according to European Clinical Trials Database record.
    • 31 Aug 2018 Biomarkers information updated
    • 17 Jun 2018 Interim results (n=13; cut off: 12 September 2017) presented at the 23rd Congress of the European Haematology Association
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