Last Update: Jul 18, 2024
An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
ClinicalTrials.gov Identifier:
NCT03975829
Novartis Reference Number:CDRB436G2401
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

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
Phase4
Recruiting
250
Nov 04, 2019
May 29, 2026
All
1 Year - 99 Years (Child, Adult, Older Adult)

Interventions

Drug

dabrafenib

dabrafenib oral, twice daily
Drug

trametinib

trametinib oral, once daily

Eligibility Criteria

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.

Worldwide Contacts

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Novartis Pharmaceuticals

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