Neoplasms

All Conditions

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Glioblastoma

Glioma

Neuroblastoma

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurofibroma, Plexiform

Astrocytoma

Ganglioneuroma

Oligodendroglioma

Histiocytosis, Langerhans-Cell

Histiocytosis

Ganglioglioma

Neurocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Nerve Sheath Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neurofibromatosis

Neurofibromatosis Type 1

Anaplastic Astrocytoma

Gangliocytoma

Langerhans Cell Histiocytosis

Anaplastic Oligodendroglioma

Diffuse Astrocytoma

Pilocytic Astrocytoma

Pleomorphic Xanthoastrocytoma

Anaplastic Pleomorphic Xanthoastrocytoma

Anaplastic Ganglioglioma

Desmoplastic Infantile Astrocytoma

Papillary Glioneuronal Tumors

Central Neurocytoma

Chordoid Glioma of the Third Ventricle

Cerebellar Liponeurocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Trametinib

Dabrafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

dabrafenib

trametinib

Novartis Pharmaceuticals

Jessica Sollitto

Stephen Gilheeney

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

Pediatric Long-Term Follow-up and Rollover Study

An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.

Developmental monitoring: Serial measurements of height will be collected throughout the study

Developmental monitoring: Serial measurements of weight will be collected throughout the study

Developmental monitoring: Serial measurements of skeletal maturation will be collected throughout the study

Developmental monitoring: Serial measurements of sexual maturation will be collected throughout the study

Developmental monitoring: Serial measurements of cardiac function will be collected throughout the study

Disease specific clinical benefit, as determined by investigator using institutional standard of care. Investigator will measure tumor response based on the Response Assessment used for the subject in the parent protocol (Response Assessment in Neuro-Oncology (RANO) criteria for solid tumors, RECIST, NF1 Volumetric, Neuroblastoma, or LCH criteria).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pediatric Long-Term Follow-up and Rollover Study	NCT03975829	Diffuse Astrocy... Anaplastic Astr... Astrocytoma Oligodendroglio... Anaplastic Olig... Glioblastoma Pilocytic Astro... Giant Cell Astr... Pleomorphic Xan... Anaplastic Pleo... Angiocentric Gl... Chordoid Glioma... Gangliocytoma Ganglioglioma Anaplastic Gang... Dysplastic Gang... Desmoplastic In... Papillary Glion... Rosette-forming... Central Neurocy... Extraventricula... Cerebellar Lipo... Neurofibromatos...	dabrafenib trametinib	1 Year -	Novartis
Pediatric Long-Term Follow-up and Rollover Study	NCT03975829	Diffuse Astrocy... Anaplastic Astr... Astrocytoma Oligodendroglio... Anaplastic Olig... Glioblastoma Pilocytic Astro... Giant Cell Astr... Pleomorphic Xan... Anaplastic Pleo... Angiocentric Gl... Chordoid Glioma... Gangliocytoma Ganglioglioma Anaplastic Gang... Dysplastic Gang... Desmoplastic In... Papillary Glion... Rosette-forming... Central Neurocy... Extraventricula... Cerebellar Lipo... Neurofibromatos...	dabrafenib trametinib	1 Year -	Novartis
Pediatric Long-Term Follow-up and Rollover Study	NCT03975829	Diffuse Astrocy... Anaplastic Astr... Astrocytoma Oligodendroglio... Anaplastic Olig... Glioblastoma Pilocytic Astro... Giant Cell Astr... Pleomorphic Xan... Anaplastic Pleo... Angiocentric Gl... Chordoid Glioma... Gangliocytoma Ganglioglioma Anaplastic Gang... Dysplastic Gang... Desmoplastic In... Papillary Glion... Rosette-forming... Central Neurocy... Extraventricula... Cerebellar Lipo... Neurofibromatos...	dabrafenib trametinib	1 Year -	Novartis

Spots Global Cancer Trial Database for cerebellar liponeurocytoma