Pediatric Long-Term Follow-up and Rollover Study
M
Michael Ferguson, MD
Primary Investigator
Overview
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenibd/or trametinib.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
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
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Age: 1 Year
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Gender: All
Key Inclusion Criteria:
All Subjects:
- Written informed consent, according to local guidelines, signed by the subjects and/orby the parents or legal guardian prior to any study related screening procedures ared.
- 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 theudy protocol requirement(s).
- Willingness and ability to comply with scheduled visits, treatment plans and any otherudy procedures.
For Subjects Entering the Treatment Period:
- Subject is currently receiving treatment with dabrafenib/trametinib monotherapy orbination within a Novartis Sponsored Drug Development study. Note that subjects whowere on the chemotherapy arm of the CDRB436G2201 study are eligible for treatmentd of this study only after crossing over into the experimental treatment arm ofhe 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 wasdispensed in combination with another study medication.
For Subjects Entering the Treatment Period:
- Subject has permanently discontinued from study treatment in the parent protocol duey reason.
- Treatment with dabrafenib and/or trametinib for the subject's indication is approvedketing and the appropriate dosage form is commercially available and reimbursedhe local country
- Subject currently has unresolved drug related severe toxicities for which dabrafenibd/or trametinib dosing has been interrupted in the parent study. If the subjecthould meet criteria to resume treatment on the parent protocol then they may begible for treatment in this study.
Other protocol-defined inclusion/exclusion may apply.
Updated on
30 Apr 2024.
Study ID: CDRB436G2401
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