Pediatric Long-Term Follow-up and Rollover Study

  • STATUS
    Recruiting
  • End date
    May 29, 2026
  • participants needed
    250
  • sponsor
    Novartis Pharmaceuticals
Updated on 28 April 2021
trametinib
dabrafenib

Summary

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

Details
Condition Neurofibromatosis, von Recklinghausen's Disease, Ganglioneuroma, Oligodendroglioma, Astrocytoma, Glioma, Peripheral Neuropathy, Glioblastoma Multiforme, Malignant neoplasm of brain, Ganglioglioma, Neurocytoma, Brain Tumor (Pediatric), Pleomorphic Xanthoastrocytoma, Anaplastic Ganglioglioma, Giant Cell Astrocytoma, Anaplastic Pleomorphic Xanthoastrocytoma, Angiocentric Glioma, Chordoid Glioma of Third Ventricle, Dysplastic Gangliocytoma of Cerebrellum, Desmoplastic Infantile Astrocytoma and Ganglioglioma, Papillary Glioneuronal Tumor, Extraventricular Neurocytoma, Brain Cancer, Gliomas, Brain Tumor, Rosette-forming Glioneurona Tumor, Cerebellar Liponeurocytoma, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gangliogliomas, astrocytoma, anaplastic, oligodendroglioma, anaplastic, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor, Rosette-forming Glioneurona Tumor
Treatment Dabrafenib, Trametinib
Clinical Study IdentifierNCT03975829
SponsorNovartis Pharmaceuticals
Last Modified on28 April 2021

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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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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