CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 165 enrolled / 165 target
Drug / intervention
dabrafenib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03975829
NCT03975829Phase 4ActiveOn Track (2.1/mo)
CompareCT.gov

An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

Novartis Pharmaceuticals·interventional·Posted Jun 5, 2019·Updated Jun 26, 2026

In Brief

A Phase 4 clinical trial evaluating dabrafenib and trametinib for Diffuse Astrocytoma and 22 related conditions. Active but no longer recruiting, targeting 165 participants across 55 sites in 19 countries.

Detailed Summary

A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse 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
CountriesArgentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 4Active
20202021202220232024202520262027
First PostedJun 5, 2019
Enrollment StartNov 4, 2019
Primary CompletionNov 5, 2026
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 7.1 years agoPrimary completion in 4 months

Arms & Interventions

Dabrafenib and/or trametinibexperimental

Patients in this study may receive one of the following treatments received in the parent study which are: * Patients who received monotherapy of either of dabrafenib or trametinib * Patients who received combination of dabrafenib and trametinib * Patients who discontinued treatment on parent study are still offered to participate in long-term follow-up

Drug: dabrafenibDrug: trametinib

Interventions

dabrafenibdrug

dabrafenib oral, twice daily

trametinibdrug

trametinib oral, once daily