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Clinical Trials in the UK / NCT03975829
Active, not recruiting Phase 4

Pediatric Long-Term Follow-up and Rollover Study

NCT03975829 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Started
2019-11-04
Last updated
2026-08-27

Condition(s) studied

Diffuse AstrocytomaAnaplastic AstrocytomaAstrocytomaOligodendroglioma, ChildhoodAnaplastic OligodendrogliomaGlioblastomaPilocytic AstrocytomaGiant Cell AstrocytomaPleomorphic XanthoastrocytomaAnaplastic Pleomorphic XanthoastrocytomaAngiocentric GliomaChordoid Glioma of Third VentricleGangliocytomaGangliogliomaAnaplastic GangliogliomaDysplastic Gangliocytoma of CerebrellumDesmoplastic Infantile Astrocytoma and GangliogliomaPapillary Glioneuronal TumorRosette-forming Glioneuronal TumorCentral NeurocytomaExtraventricular NeurocytomaCerebellar LiponeurocytomaNeurofibromatosis Type 1

Investigational drug(s) / intervention(s)

dabrafenibtrametinib

dabrafenib: dabrafenib oral, twice daily

trametinib: trametinib oral, once daily

Study summary

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

Eligibility

Sex
ALL
Min age
1 Year
Max age
99 Years
Healthy volunteers
No
Key Inclusion Criteria: All Subjects: * 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. For Subjects Entering the Treatment Period: * 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. Key Exclusion Criteria: All Subjects: \- Subject has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication. For Subjects Entering the Treatment Period: * 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. Other protocol-defined inclusion/exclusion may apply.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Phoenix Children s Hospital Phoenix Arizona
Childrens National Hospital Washington D.C. District of Columbia
Nicklaus Childrens Hospital Miami Florida
Indiana Uni School of Medicine Indianapolis Indiana
Johns Hopkins Hospital Baltimore Maryland
Dana Farber Cancer Institute Boston Massachusetts
University of Minnesota Minneapolis Minnesota
Memorial Sloan Kettering Cancer Ctr New York New York
Cinn Children Hosp Medical Center Cincinnati Ohio
St Jude Childrens Research Hospital Memphis Tennessee
Texas Childrens Hospital Houston Texas
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Darlinghurst New South Wales
Novartis Investigative Site Parkville Victoria
Novartis Investigative Site Brussels Belgium
Novartis Investigative Site Barretos São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Vancouver British Columbia
Novartis Investigative Site Toronto Ontario
Novartis Investigative Site Montreal Quebec
Novartis Investigative Site Brno Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Copenhagen Denmark
Novartis Investigative Site Tampere Finland
Novartis Investigative Site Rennes Brittany Region
Novartis Investigative Site Brest France
Novartis Investigative Site Marseille France
Novartis Investigative Site Paris France
Novartis Investigative Site Rennes France
Novartis Investigative Site Vandœuvre-lès-Nancy France
Novartis Investigative Site Villejuif France
Novartis Investigative Site Cologne North Rhine-Westphalia
Novartis Investigative Site Augsburg Germany
Novartis Investigative Site Berlin Germany
Novartis Investigative Site Essen Germany
Novartis Investigative Site Hamburg Germany
Novartis Investigative Site Petah Tikva Israel
Novartis Investigative Site Florence FI
Novartis Investigative Site Genova GE

+ 14 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03975829 on ClinicalTrials.gov ↗ ← All trials in the UK