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: 16 Aug 2017

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

    • 20 Jul 2017 Planned End Date changed from 1 Sep 2018 to 2 Sep 2019.
    • 20 Jul 2017 Planned primary completion date changed from 1 Mar 2018 to 2 Mar 2019.
    • 10 Jun 2017 Biomarkers information updated
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