Trials / Active Not Recruiting
Active Not RecruitingNCT03975829
Pediatric Long-Term Follow-up and Rollover Study
An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 163 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Year – 99 Years
- Healthy volunteers
- Not accepted
Summary
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Conditions
- Diffuse Astrocytoma
- Anaplastic Astrocytoma
- Astrocytoma
- Oligodendroglioma, Childhood
- Anaplastic Oligodendroglioma
- Glioblastoma
- Pilocytic Astrocytoma
- Giant Cell Astrocytoma
- Pleomorphic Xanthoastrocytoma
- Anaplastic Pleomorphic Xanthoastrocytoma
- Angiocentric Glioma
- Chordoid Glioma of Third Ventricle
- Gangliocytoma
- Ganglioglioma
- Anaplastic Ganglioglioma
- Dysplastic Gangliocytoma of Cerebrellum
- Desmoplastic Infantile Astrocytoma and Ganglioglioma
- Papillary Glioneuronal Tumor
- Rosette-forming Glioneuronal Tumor
- Central Neurocytoma
- Extraventricular Neurocytoma
- Cerebellar Liponeurocytoma
- Neurofibromatosis Type 1
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dabrafenib | dabrafenib oral, twice daily |
| DRUG | trametinib | trametinib oral, once daily |
Timeline
- Start date
- 2019-11-04
- Primary completion
- 2026-11-05
- Completion
- 2026-11-05
- First posted
- 2019-06-05
- Last updated
- 2026-04-02
Locations
55 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Russia, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03975829. Inclusion in this directory is not an endorsement.