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Pediatric Long-Term Follow-up and Rollover Study
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Conditions:
🦠 Diffuse Astrocytoma 🦠 Anaplastic Astrocytoma 🦠 Astrocytoma 🦠 Oligodendroglioma, Childhood 🦠 Anaplastic Oligodendroglioma 🦠 Glioblastoma 🦠 Pilocytic Astrocytoma 🦠 Giant Cell Astrocytoma 🦠 Pleomorphic Xanthoastrocytoma 🦠 Anaplastic Pleomorphic Xanthoastrocytoma 🦠 Angiocentric Glioma 🦠 Chordoid Glioma of Third Ventricle 🦠 Gangliocytoma 🦠 Ganglioglioma 🦠 Anaplastic Ganglioglioma 🦠 Dysplastic Gangliocytoma of Cerebrellum 🦠 Desmoplastic Infantile Astrocytoma and Ganglioglioma 🦠 Papillary Glioneuronal Tumor 🦠 Rosette-forming Glioneurona Tumor 🦠 Central Neurocytoma 🦠 Extraventricular Neurocytoma 🦠 Cerebellar Liponeurocytoma 🦠 Neurofibromatosis Type 1
More conditions available...
🗓️ Study Start (Actual) 4 November 2019
🗓️ Primary Completion (Estimated) 29 May 2026
✅ Study Completion (Estimated) 29 May 2026
👥 Enrollment (Estimated) 250
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Phoenix, Arizona, United States
📍 Washington, District of Columbia, United States
📍 Miami, Florida, United States
📍 Indianapolis, Indiana, United States
📍 Baltimore, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Minneapolis, Minnesota, United States
📍 New York, New York, United States
📍 Cincinnati, Ohio, United States
📍 Memphis, Tennessee, United States
📍 Houston, Texas, United States
📍 Caba, Buenos Aires, Argentina
📍 Darlinghurst, New South Wales, Australia
📍 Parkville, Victoria, Australia
📍 Bruxelles, Belgium
📍 Barretos, SP, Brazil
📍 Sao Paulo, SP, Brazil
📍 Sao Paulo, SP, Brazil
📍 Vancouver, British Columbia, Canada
📍 Toronto, Ontario, Canada
📍 Montreal, Quebec, Canada
📍 Brno, Czechia
📍 Praha 5, Czechia
📍 Copenhagen, Denmark
📍 Tampere, Finland
📍 Rennes, Bretagne, France
📍 Brest Cedex, Finistere, France
📍 Marseille, France
📍 Paris, France
📍 Rennes, France
📍 Vandoeuvre Les Nancy, France
📍 Villejuif, France
📍 Augsburg, Germany
📍 Berlin, Germany
📍 Essen, Germany
📍 Hamburg, Germany
📍 Koeln, Germany
📍 Petach Tikva, Israel
📍 Firenze, FI, Italy
📍 Genova, GE, Italy
📍 Milano, MI, Italy
📍 Roma, RM, Italy
📍 Torino, TO, Italy
📍 Setagaya-ku, Tokyo, Japan
📍 Osaka, Japan
📍 Utrecht, CS, Netherlands
📍 Moscow, Russian Federation
📍 Madrid, Spain
📍 Valencia, Spain
📍 Stockholm, Sweden
📍 Sutton, Surrey, United Kingdom
📍 Liverpool, United Kingdom
📍 London, United Kingdom
📍 London, United Kingdom
More locations available...

📋 Eligibility Criteria

Description

    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.

    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.
Ages Eligible for Study: 1 Year to 99 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 May 2019
  • First Submitted that Met QC Criteria 4 June 2019
  • First Posted 5 June 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified July 2024
I'm interested ...!!