Back to search results

Long-Term Follow-up for Pediatric Brain Tumors

This study is for children and young adults (ages 1 to 99) who have previously participated in specific Novartis studies (CTMT212X2101, CDRB436G2201, CDRB436A2102) and were treated with dabrafenib and/or trametinib. These medications work by targeting the RAF mechanism, which is involved in cancer growth. The purpose of this study is to understand the long-term effects of these treatments in patients with certain types of brain tumors, including astrocytoma and oligodendroglioma. Researchers will be looking at how many participants experience side effects (Adverse Events and Serious Adverse Events) over approximately 7 years. The study is currently ongoing, but its exact status is unclear, and it plans to enroll 163 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a rollover study, designed to assess long-term effects in patients previously treated with dabrafenib and/or trametinib.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Adverse Events and Serious Adverse Events for up to approximately 7 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03975829

Pediatric Long-Term Follow-up and Rollover Study

Active, Not Recruiting
PHASE4Ages 1–99InterventionalTreatment
Novartis Pharmaceuticals
~163 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:dabrafenibtrametinib

At a glance

Recruiting sites
0 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse Events and Serious Adverse Events (SAEs)
Measured over Baseline up to approximately 7 years

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

Explore related trials

Anaplastic AstrocytomaAnaplastic GangliogliomaAnaplastic OligodendrogliomaAnaplastic Pleomorphic XanthoastrocytomaAngiocentric GliomaAstrocytomaCentral NeurocytomaCerebellar LiponeurocytomaChordoid GliomaDesmoplastic infantile astrocytoma and gangliogliomaDiffuse AstrocytomaDysplastic Cerebellar GangliocytomaExtraventricular NeurocytomaGangliocytomaGangliogliomaGiant cell astrocytomaGlioblastomaLangerhans Cell HistiocytosisNeuroblastomaNeurofibromatosis Type 1OligodendrogliomaPapillary Glioneuronal TumorPilocytic AstrocytomaPleomorphic XanthoastrocytomaRosette-Forming Glioneuronal TumorBRAF Gene

Where it's being run

54 sites across 40 states
France6
Germany4
São Paulo3
United Kingdom3
Czechia2
Spain2
Arizona1
District of Columbia1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Written informed consent, according to local guidelines, signed by the subjects and/or by the parents or legal guardian prior to any study related screening procedures are performed.
Participation in a Novartis sponsored study such as CTMT212X2101, CDRB436G2201, CDRB436A2102, regardless of current age.
Parent study (or cohort of parent study) is planned to be closed.
Subject has demonstrated compliance, as assessed by the investigator, within the parent study protocol requirement(s).
Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
Subject is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis Sponsored Drug Development study. Note that subjects who were on the chemotherapy arm of the CDRB436G2201 study are eligible for treatment period of this study only after crossing over into the experimental treatment arm of the CDRB436G2201 study
In the opinion of the investigator is likely to benefit from continued treatment.

Exclusion

Subject has permanently discontinued from study treatment in the parent protocol due to any reason.
Treatment with dabrafenib and/or trametinib for the subject's indication is approved for marketing and the appropriate dosage form is commercially available and reimbursed in the local country
Subject currently has unresolved drug related severe toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study. If the subject should meet criteria to resume treatment on the parent protocol then they may be eligible for treatment in this study.

What this trial measures

  • Number of participants with Adverse Events and Serious Adverse Events (SAEs)Baseline up to approximately 7 years

    To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.