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

Last Update: Mar 31, 2023

See if you pre-qualify

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
Start date 
Nov 04, 2019
Completion date 
Jul 20, 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
Contact: Felicia Frank (602-546-0895) - [email protected] - Lindsey Hoffman
United States
Childrens National Hospital CQTI571A2306
Recruiting
Washington, 20010 - District of Columbia
Contact: Marie Fatil (202-476-6083) - [email protected] - Lindsay Kilburn
United States
Nicklaus Childrens Hospital
Recruiting
Miami, 33155 - Florida
Contact: Barbara Fernandez (786-624-4908) - [email protected] - Ziad Khatib
United States
Indiana University School of Medicine .
Recruiting
Indianapolis, 46202-2810 - Indiana
Contact: Michael Ferguson
United States
Johns Hopkins University IDS Pharmacy
Recruiting
Baltimore, 21287 - Maryland
Contact: Tammy Scott - [email protected] - Kenneth J Cohen
United States
Dana Farber Cancer Institute .
Recruiting
Boston, 02215 - Massachusetts
Contact: Alexa Stathis (617-632-4907) - [email protected] - Karen Wright
United States
University of Minnesota .
Recruiting
Minneapolis, 55455 - Minnesota
Contact: (651-220-6000) Christopher Moertel
United States
Memorial Sloan Kettering Cancer Center
Recruiting
New York, 10065 - New York
Contact: Jessica Sollitto (212-639-3112) - [email protected] - Stephen Gilheeney
United States
Cinn Children Hosp Medical Center
Recruiting
Cincinnati, 45229-3039 - Ohio
Contact: Lori Backus (800-344-2462) - [email protected] - Brian Weiss
United States
St Jude Children's Research Hospital .
Recruiting
Memphis, 38105 - Tennessee
Contact: Melissa Johnson (901-521-9005) - [email protected] - Santhosh Upadhyaya
United States
Texas Children's Hospital
Recruiting
Houston, 77030 - Texas
Contact: Najeeba Ali (832-822-1630) - [email protected] - Patricia A Baxter
United States
Australia
Novartis Investigative Site
Recruiting
Parkville, 3052
Victoria
Australia
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1200
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Barretos, 14784 400
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 08270-070
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,
SP
Brazil
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1X8
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1C5
Quebec
Canada
Czech Republic
Novartis Investigative Site
Recruiting
Brno, 613 00
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czech Republic
Denmark
Novartis Investigative Site
Recruiting
Copenhagen, DK-2100
-
Denmark
Finland
Novartis Investigative Site
Recruiting
Tampere, 33521
-
Finland
France
Novartis Investigative Site
Recruiting
Rennes, 35203
Bretagne
France
Novartis Investigative Site
Recruiting
Marseille Cedex 05, 13885
-
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
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86179
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20246
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Israel
Novartis Investigative Site
Recruiting
Petach-Tikva, 49202
-
Israel
Italy
Novartis Investigative Site
Recruiting
Firenze, 50139
FI
Italy
Novartis Investigative Site
Recruiting
Genova, 16147
GE
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Roma, 00165
RM
Italy
Novartis Investigative Site
Recruiting
Torino, 10126
TO
Italy
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 157-8535
Tokyo
Japan
Novartis Investigative Site
Recruiting
Osaka, 534-0021
-
Japan
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3584
CS
Netherlands
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 117198
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
-
Spain
Sweden
Novartis Investigative Site
Recruiting
Stockholm, 17176
-
Sweden
United Kingdom
Novartis Investigative Site
Recruiting
Sutton, SM2 5PT
Surrey
United Kingdom
Novartis Investigative Site
Recruiting
Liverpool, L12 2AP
-
United Kingdom
Novartis Investigative Site
Recruiting
London, WC1N 3JH
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]