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ACTIVE NOT RECRUITING

NCT03975829

PHASE4

Pediatric Long-Term Follow-up and Rollover Study

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

Key Details

Gender

All

Age Range

1 Year - 99 Years

Study Type

INTERVENTIONAL

Enrollment

163

Start Date

2019-11-04

Completion Date

2026-11-05

Last Updated

2026-04-02

Healthy Volunteers

Interventions

DRUG

dabrafenib

dabrafenib oral, twice daily

DRUG

trametinib

trametinib oral, once daily

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.

Locations (55)

Phoenix Children s Hospital

Phoenix, Arizona, United States

Childrens National Hospital

Washington D.C., District of Columbia, United States

Nicklaus Childrens Hospital

Miami, Florida, United States

Indiana Uni School of Medicine

Indianapolis, Indiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Ctr

New York, New York, United States

Cinn Children Hosp Medical Center

Cincinnati, Ohio, United States

St Jude Childrens Research Hospital

Memphis, Tennessee, United States

Texas Childrens Hospital

Houston, Texas, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Novartis Investigative Site

Parkville, Victoria, Australia

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Copenhagen, Denmark

Novartis Investigative Site

Tampere, Finland

Novartis Investigative Site

Rennes, Brittany Region, France

Novartis Investigative Site

Brest, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Rennes, France

Novartis Investigative Site

Vandœuvre-lès-Nancy, France

Novartis Investigative Site

Villejuif, France

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Augsburg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Setagaya-ku, Tokyo, Japan

Novartis Investigative Site

Osaka, Japan

Novartis Investigative Site

Utrecht, Netherlands

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Stockholm, Sweden

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Novartis Investigative Site

Liverpool, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Clinical Research Directory

Pediatric Long-Term Follow-up and Rollover Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (55)