Pediatric Long-Term Follow-up and Rollover Study

Last updated: April 8, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Neurofibromatosis

Precancerous Condition

Cancer

Treatment

dabrafenib

trametinib

Clinical Study ID

NCT03975829
CDRB436G2401
2018-004459-19
  • Ages 1-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

All Subjects:

  • Written informed consent, according to local guidelines, signed by the subjectsand/or by the parents or legal guardian prior to any study related screeningprocedures 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 theparent study protocol requirement(s).

  • Willingness and ability to comply with scheduled visits, treatment plans and anyother study procedures.

For Subjects Entering the Treatment Period:

  • Subject is currently receiving treatment with dabrafenib/trametinib monotherapy orcombination within a Novartis Sponsored Drug Development study. Note that subjectswho were on the chemotherapy arm of the CDRB436G2201 study are eligible fortreatment period of this study only after crossing over into the experimentaltreatment arm of the CDRB436G2201 study

  • In the opinion of the investigator is likely to benefit from continued treatment.

Exclusion

Key Exclusion Criteria:

All Subjects:

  • Subject has participated in a combination trial where dabrafenib and/or trametinibwas dispensed in combination with another study medication.

For Subjects Entering the Treatment Period:

  • Subject has permanently discontinued from study treatment in the parent protocol dueto any reason.

  • Treatment with dabrafenib and/or trametinib for the subject's indication is approvedfor marketing and the appropriate dosage form is commercially available andreimbursed in the local country

  • Subject currently has unresolved drug related severe toxicities for which dabrafeniband/or trametinib dosing has been interrupted in the parent study. If the subjectshould meet criteria to resume treatment on the parent protocol then they may beeligible for treatment in this study.

Other protocol-defined inclusion/exclusion may apply.

Study Design

Total Participants: 164
Treatment Group(s): 2
Primary Treatment: dabrafenib
Phase: 4
Study Start date:
November 04, 2019
Estimated Completion Date:
July 22, 2026

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1428AQK
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Novartis Investigative Site

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Novartis Investigative Site

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Barretos, SP 14784 400
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 08270-070
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Novartis Investigative Site

    Brno, 613 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Brno Bohunice, 625 00
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Tampere, 33521
    Finland

    Site Not Available

  • Novartis Investigative Site

    Brest Cedex, Finistere 29609
    France

    Site Not Available

  • Novartis Investigative Site

    Brest, 29609
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille, 13885
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille Cedex, 13385
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille Cedex 05, 13885
    France

    Site Not Available

  • Novartis Investigative Site

    Marseille Cedex 5, 13385
    France

    Site Not Available

  • Novartis Investigative Site

    Paris, 75231
    France

    Site Not Available

  • Novartis Investigative Site

    Rennes, 35033
    France

    Site Not Available

  • Novartis Investigative Site

    Vandoeuvre Les Nancy, 54511
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif, 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif Cedex, 94800
    France

    Site Not Available

  • Novartis Investigative Site

    Augsburg, 86179
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 20246
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Petach Tikva, 49202
    Israel

    Site Not Available

  • Novartis Investigative Site

    Petach-Tikva, 49202
    Israel

    Site Not Available

  • Novartis Investigative Site

    Firenze, FI 50139
    Italy

    Site Not Available

  • Novartis Investigative Site

    Genova, GE 16147
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20133
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma, RM 00165
    Italy

    Site Not Available

  • Novartis Investigative Site

    Torino, TO 10126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 157-8535
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 534-0021
    Japan

    Site Not Available

  • Novartis Investigative Site

    Utrecht, CS 3584
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Moscow, 117198
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, 46026
    Spain

    Site Not Available

  • Novartis Investigative Site

    Stockholm, 17176
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London, WC1N 3JH
    United Kingdom

    Site Not Available

  • Phoenix Children s Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Phoenix Children s Hospital .

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Phoenix Children's Hospital .

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Childrens National Hospital CQTI571A2306

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Nicklaus Childrens Hospital

    Miami, Florida 33155
    United States

    Site Not Available

  • Indiana Uni School of Medicine

    Indianapolis, Indiana 46202-2810
    United States

    Site Not Available

  • Indiana Uni School of Medicine .

    Indianapolis, Indiana 46202-2810
    United States

    Site Not Available

  • Indiana University School of Medicine .

    Indianapolis, Indiana 46202-2810
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Hospital Main Centre

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins University IDS Pharmacy

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute .

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota .

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Cinn Children Hosp Medical Center

    Cincinnati, Ohio 45229-3039
    United States

    Site Not Available

  • St Jude Children's Research Hospital .

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • St Jude Childrens Research Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • St Jude Childrens Research Hospital .

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Childrens Hospital

    Houston, Texas 77030
    United States

    Site Not Available

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