Pediatric Long-Term Follow-up and Rollover Study

Novartis

Status and phase: Active, not recruiting; Phase 4

Conditions: Neurofibromatosis Type 1; Glioblastoma; Chordoid Glioma of Third Ventricle; Papillary Glioneuronal Tumor; Ganglioglioma; Pilocytic Astrocytoma; Extraventricular Neurocytoma; Gangliocytoma; Cerebellar Liponeurocytoma; Giant Cell Astrocytoma; Anaplastic Astrocytoma; Angiocentric Glioma; Anaplastic Ganglioglioma; Desmoplastic Infantile Astrocytoma and Ganglioglioma; Astrocytoma; Central Neurocytoma; Dysplastic Gangliocytoma of Cerebrellum; Oligodendroglioma, Childhood; Rosette-forming Glioneuronal Tumor; Pleomorphic Xanthoastrocytoma; Diffuse Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Pleomorphic Xanthoastrocytoma

Treatments: Drug: trametinib; Drug: dabrafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03975829

2023-509276-42-00 (Registry Identifier)

CDRB436G2401

Details and patient eligibility

About

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

Enrollment: 165 patients

Sex: All

Ages: 1 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

Dabrafenib and/or trametinib

Experimental group

Description:

Patients in this study may receive one of the following treatments received in the parent study which are: * Patients who received monotherapy of either of dabrafenib or trametinib * Patients who received combination of dabrafenib and trametinib * Patients who discontinued treatment on parent study are still offered to participate in long-term follow-up

Treatment:

Drug: trametinib

Drug: dabrafenib