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Kids' brain tumor drugs tested for Long-Term safety

NCT ID NCT03975829

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 7 times

Summary

This study follows 165 children who previously took dabrafenib and/or trametinib for certain brain tumors. Researchers want to see if these drugs are safe over the long term and how they affect growth. The children continue their treatment and are monitored for side effects and developmental changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dabrafenib and/or trametinib
What this could lead to
If successful, this study could confirm that long-term use of these drugs is safe for children with certain brain tumors, supporting their continued use.
What could go wrong
This is a roll-over study, not a new treatment test. It focuses on safety and growth, not on curing the disease. Side effects or developmental issues may still arise.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

163 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anaplastic astrocytoma anaplastic ganglioglioma anaplastic oligodendroglioma anaplastic pleomorphic xanthoastrocytoma angiocentric glioma astrocytoma (excluding glioblastoma) central neurocytoma cerebellar liponeurocytoma childhood oligodendroglioma chordoid glioma of the third ventricle desmoplastic infantile astrocytoma/ganglioglioma diffuse astrocytoma extraventricular neurocytoma gangliocytoma ganglioglioma glioblastoma glioma Histiocytosis, Langerhans-Cell neuroblastoma neurofibromatosis type 1 oligodendroglioma papillary glioneuronal tumor pilocytic astrocytoma pleomorphic xanthoastrocytoma plexiform neurofibroma rosette-forming glioneuronal tumor of fourth ventricule

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anaplastic astrocytoma Anaplastic ganglioglioma Anaplastic oligodendroglioma Anaplastic pleomorphic xanthoastrocytoma Angiocentric glioma Astrocytoma Central neurocytoma Cerebellar liponeurocytoma Chordoid glioma of third ventricle Desmoplastic infantile astrocytoma and ganglioglioma Diffuse astrocytoma Dysplastic gangliocytoma of cerebrellum Extraventricular neurocytoma Gangliocytoma Ganglioglioma Giant cell astrocytoma Glioblastoma Neurofibromatosis type 1 Oligodendroglioma, childhood Papillary glioneuronal tumor Pilocytic astrocytoma Pleomorphic xanthoastrocytoma Rosette-forming glioneuronal tumor

Contacts and locations

Locations

  • Childrens National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Cinn Children Hosp Medical Center

    Cincinnati, Ohio, 45229-3039, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Indiana Uni School of Medicine

    Indianapolis, Indiana, 46202-2810, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Memorial Sloan Kettering Cancer Ctr

    New York, New York, 10065, United States

  • Nicklaus Childrens Hospital

    Miami, Florida, 33155, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1428AQK, Argentina

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    Parkville, Victoria, 3052, Australia

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04829-310, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 08270-070, Brazil

  • Novartis Investigative Site

    Vancouver, British Columbia, V6H 3V4, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 1X8, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Copenhagen, 2100, Denmark

  • Novartis Investigative Site

    Tampere, Finland, 33521, Finland

  • Novartis Investigative Site

    Rennes, Brittany Region, 35203, France

  • Novartis Investigative Site

    Brest, 29609, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Paris, 75231, France

  • Novartis Investigative Site

    Rennes, 35033, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Augsburg, 86179, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Petah Tikva, 4920235, Israel

  • Novartis Investigative Site

    Florence, FI, 50139, Italy

  • Novartis Investigative Site

    Genova, GE, 16147, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Osaka, Osaka, 5340021, Japan

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 1578535, Japan

  • Novartis Investigative Site

    Utrecht, Utrecht, 3584 CS, Netherlands

  • Novartis Investigative Site

    Moscow, 117198, Russia

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Stockholm, 17176, Sweden

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    Liverpool, L12 2AP, United Kingdom

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • Novartis Investigative Site

    London, WC1N 3JH, United Kingdom

  • Phoenix Children s Hospital

    Phoenix, Arizona, 85016, United States

  • St Jude Childrens Research Hospital

    Memphis, Tennessee, 38105, United States

  • Texas Childrens Hospital

    Houston, Texas, 77030, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

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