Pediatric Long-Term Follow-up and Rollover Study

STATUS

Recruiting
End date

Jul 20, 2026
participants needed

250
sponsor

Novartis Pharmaceuticals

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Updated on 12 April 2023

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trametinib

dabrafenib

Summary

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

Details

Condition	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 Glioneurona Tumor, Central Neurocytoma, Extraventricular Neurocytoma, Cerebellar Liponeurocytoma, Neurofibromatosis Type 1
Treatment	Dabrafenib, Trametinib
Clinical Study Identifier	NCT03975829
Sponsor	Novartis Pharmaceuticals
Last Modified on	12 April 2023

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Eligibility		Yes	No	Not Sure
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
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

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Step 2 Get screened

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Pediatric Long-Term Follow-up and Rollover Study