Actively Recruiting

Phase 4
Age: 1Year - 99Years
All Genders
NCT03975829

Pediatric Long-Term Follow-up and Rollover Study

Led by Novartis Pharmaceuticals · Updated on 2026-05-11

165

Participants Needed

55

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Pediatric Long-Term Follow-up and Rollover Study

Who Can Participate

Age: 1Year - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent signed by the subject and/or parent or guardian before any study procedures
  • Participation in a Novartis-sponsored study such as CTMT212X2101, CDRB436G2201, or CDRB436A2102
  • Planned closure of the parent study or cohort
  • Compliance with the parent study protocol as assessed by the investigator
  • Willingness and ability to follow scheduled visits, treatment plans, and study procedures
  • Currently receiving dabrafenib and/or trametinib monotherapy or combination within a Novartis-sponsored study
  • Investigator believes the subject will benefit from continued treatment
Not Eligible

You will not qualify if you...

  • Participation in a combination trial where dabrafenib and/or trametinib was combined with another study medication
  • Permanent discontinuation of study treatment in the parent protocol for any reason
  • Dabrafenib and/or trametinib approved and commercially available with reimbursement for the subject's condition in the local country
  • Unresolved severe drug-related toxicities causing interrupted dosing in the parent study
  • Other protocol-defined inclusion or exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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, 45206

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

Actively 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

Actively Recruiting

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

Loading map...

Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

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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