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)
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.
Trial sites (54)
Facility
City
Region
Status
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.
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.
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