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)

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.

Condition 
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
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
250 participants
Start date 
Nov 04, 2019
Completion date 
May 29, 2026
Gender 
All
Age(s)
1 Years and older (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.

Study Locations

United States
Phoenix Childrens Hospital
Recruiting
Phoenix, 85016
Arizona
United States
Johns Hopkins University IDS Pharmacy
Recruiting
Baltimore, 21287
Maryland
United States
Dana Farber Cancer Institute
Recruiting
Boston, 02215
Massachusetts
United States
Memorial Sloan Kettering Cancer Center
Recruiting
New York, 10065
New York
United States
Cincinnati Children s Hospital Medical Center
Recruiting
Cincinnati, 45229-3039
Ohio
United States
St Jude Children's Research Hospital
Recruiting
Memphis, 38105
Tennessee
United States
France
Novartis Investigative Site
Recruiting
Rennes, 35203
Bretagne
France
Novartis Investigative Site
Recruiting
Marseille Cedex 5, 13385
-
France
Novartis Investigative Site
Recruiting
Paris, 75231
-
France
Novartis Investigative Site
Recruiting
Vandoeuvre Les Nancy, 54511
-
France
Novartis Investigative Site
Recruiting
Villejuif Cedex, 94800
-
France
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
United Kingdom
Novartis Investigative Site
Recruiting
London, WC1N 3JH
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]