Clinical Trials in Italy / NCT03975829
Active, not recruiting
Phase 4
Pediatric Long-Term Follow-up and Rollover Study
NCT03975829 · tracked via the Priya Life Science Italy tracker
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)
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
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.
More Novartis Pharmaceuticals trials in Italy
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
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Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
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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 Italy