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RecruitingPhase 4NCT03975829

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)

Sponsor

Novartis Pharmaceuticals

Enrollment

165 participants

Start Date

Nov 4, 2019

Study Type

INTERVENTIONAL

Conditions

Neurofibromatosis Type 1GlioblastomaAnaplastic AstrocytomaAstrocytomaAnaplastic OligodendrogliomaPilocytic AstrocytomaPleomorphic XanthoastrocytomaAnaplastic Pleomorphic XanthoastrocytomaDiffuse AstrocytomaGangliogliomaOligodendroglioma, ChildhoodGiant Cell AstrocytomaAngiocentric GliomaChordoid Glioma of Third VentricleGangliocytomaAnaplastic GangliogliomaDysplastic Gangliocytoma of CerebrellumDesmoplastic Infantile Astrocytoma and GangliogliomaPapillary Glioneuronal TumorRosette-forming Glioneuronal TumorCentral NeurocytomaExtraventricular NeurocytomaCerebellar Liponeurocytoma

Summary

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

Eligibility

Min Age: 1 YearMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called dabrafenib and a drug called trametinib for people with anaplastic astrocytoma, anaplastic ganglioglioma, and other related conditions. The study is currently recruiting participants at 55 locations. People eligible for this study include aged 1 Year to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdabrafenib

dabrafenib oral, twice daily

DRUGtrametinib

trametinib oral, once daily

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

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NCT03975829

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