Actively Recruiting
An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
Led by Novartis Pharmaceuticals · Updated on 2026-06-08
165
Participants Needed
55
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term effects of the drugs dabrafenib and/or trametinib in pediatric patients who have been treated for various brain tumors and related conditions. It is an open-label, multi-center roll-over study sponsored by Novartis Pharmaceuticals, focusing on children and young adults who previously participated in related Novartis studies. The study monitors the safety and health changes over time in these patients. Participants may continue receiving the same treatment they had in the parent study, which could be either dabrafenib or trametinib alone, or a combination of both. Even those who stopped treatment in the original study can join the long-term follow-up. Dabrafenib is taken orally twice daily, and trametinib is taken orally once daily. The study is designed to follow patients for up to about 7 years. Throughout the study, researchers will assess participants regularly for any adverse or serious adverse events. They will also track changes in height, weight, bone age, sexual development, heart function, and clinical benefits using scans like CT or MRI. Participants will have scheduled visits to monitor these outcomes, ensuring comprehensive long-term observation of their health and treatment effects.
CONDITIONS
Brief Title
Pediatric Long-Term Follow-up and Rollover Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent signed by the subject or guardian before any study procedures
- Participation in a Novartis-sponsored study involving dabrafenib and/or trametinib
- Parent study or cohort is planned to be closed
- Compliance with the parent study protocol as assessed by the investigator
- Willingness and ability to follow scheduled visits, treatments, and study procedures
- Currently receiving dabrafenib or trametinib alone or in combination in a Novartis study
- Investigator believes the subject may benefit from continued treatment
You will not qualify if you...
- Participation in a combination trial where dabrafenib and/or trametinib was given with another study drug
- Permanent discontinuation from study treatment in the parent protocol
- Dabrafenib and/or trametinib treatment approved and commercially available for the subject's condition locally
- Unresolved severe drug-related toxicities causing interrupted dosing in the parent study (unless eligible to resume treatment)
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 7 years
Participants continue treatment with dabrafenib and/or trametinib as received in the parent study.
Trial Site Locations
Total: 55 locations
1
Phoenix Children s Hospital
Phoenix, Arizona, United States, 85016
Active, Not Recruiting
2
Childrens National Hospital
Washington D.C., District of Columbia, United States, 20010
Active, Not Recruiting
3
Nicklaus Childrens Hospital
Miami, Florida, United States, 33155
Active, Not Recruiting
4
Indiana Uni School of Medicine
Indianapolis, Indiana, United States, 46202-2810
Active, Not Recruiting
5
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Active, Not Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States, 10065
Active, Not Recruiting
10
Cinn Children Hosp Medical Center
Cincinnati, Ohio, United States, 45229-3039
Active, Not Recruiting
11
St Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
Active, Not Recruiting
12
Texas Childrens Hospital
Houston, Texas, United States, 77030
Completed
13
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1428AQK
Active, Not Recruiting
14
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Active, Not Recruiting
15
Novartis Investigative Site
Parkville, Victoria, Australia, 3052
Active, Not Recruiting
16
Novartis Investigative Site
Brussels, Belgium, 1200
Completed
17
Novartis Investigative Site
Barretos, São Paulo, Brazil, 14784 400
Active, Not Recruiting
18
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 04829-310
Active, Not Recruiting
19
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 08270-070
Completed
20
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6H 3V4
Active, Not Recruiting
21
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 1X8
Active, Not Recruiting
22
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1C5
Completed
23
Novartis Investigative Site
Brno, Czechia, 625 00
Active, Not Recruiting
24
Novartis Investigative Site
Prague, Czechia, 150 06
Active, Not Recruiting
25
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Active, Not Recruiting
26
Novartis Investigative Site
Tampere, Finland, 33521
Active, Not Recruiting
27
Novartis Investigative Site
Rennes, Brittany Region, France, 35203
Active, Not Recruiting
28
Novartis Investigative Site
Brest, France, 29609
Completed
29
Novartis Investigative Site
Marseille, France, 13885
Active, Not Recruiting
30
Novartis Investigative Site
Paris, France, 75231
Active, Not Recruiting
31
Novartis Investigative Site
Rennes, France, 35033
Active, Not Recruiting
32
Novartis Investigative Site
Vandœuvre-lès-Nancy, France, 54511
Active, Not Recruiting
33
Novartis Investigative Site
Villejuif, France, 94800
Active, Not Recruiting
34
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Active, Not Recruiting
35
Novartis Investigative Site
Augsburg, Germany, 86179
Active, Not Recruiting
36
Novartis Investigative Site
Berlin, Germany, 13353
Active, Not Recruiting
37
Novartis Investigative Site
Essen, Germany, 45147
Active, Not Recruiting
38
Novartis Investigative Site
Hamburg, Germany, 20246
Active, Not Recruiting
39
Novartis Investigative Site
Petah Tikva, Israel, 4920235
Completed
40
Novartis Investigative Site
Florence, FI, Italy, 50139
Active, Not Recruiting
41
Novartis Investigative Site
Genova, GE, Italy, 16147
Active, Not Recruiting
42
Novartis Investigative Site
Milan, MI, Italy, 20133
Active, Not Recruiting
43
Novartis Investigative Site
Roma, RM, Italy, 00165
Active, Not Recruiting
44
Novartis Investigative Site
Torino, TO, Italy, 10126
Active, Not Recruiting
45
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan, 1578535
Active, Not Recruiting
46
Novartis Investigative Site
Osaka, Japan, 5340021
Active, Not Recruiting
47
Novartis Investigative Site
Utrecht, Netherlands, 3584 CS
Active, Not Recruiting
48
Novartis Investigative Site
Moscow, Russia, 117198
Active, Not Recruiting
49
Novartis Investigative Site
Madrid, Spain, 28009
Active, Not Recruiting
50
Novartis Investigative Site
Valencia, Spain, 46026
Active, Not Recruiting
51
Novartis Investigative Site
Stockholm, Sweden, 17176
Completed
52
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
Active, Not Recruiting
53
Novartis Investigative Site
Liverpool, United Kingdom, L12 2AP
Active, Not Recruiting
54
Novartis Investigative Site
London, United Kingdom, NW1 2BU
Active, Not Recruiting
55
Novartis Investigative Site
London, United Kingdom, WC1N 3JH
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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