RECRUITING

Pediatric Long-Term Follow-up and Rollover Study

Description

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

Conditions

Diffuse AstrocytomaAnaplastic AstrocytomaAstrocytomaOligodendroglioma, ChildhoodAnaplastic OligodendrogliomaGlioblastomaPilocytic AstrocytomaGiant Cell AstrocytomaPleomorphic XanthoastrocytomaAnaplastic Pleomorphic XanthoastrocytomaAngiocentric GliomaChordoid Glioma of Third VentricleGangliocytomaGangliogliomaAnaplastic GangliogliomaDysplastic Gangliocytoma of CerebrellumDesmoplastic Infantile Astrocytoma and GangliogliomaPapillary Glioneuronal TumorRosette-forming Glioneuronal TumorCentral NeurocytomaExtraventricular NeurocytomaCerebellar LiponeurocytomaNeurofibromatosis Type 1
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Related Conditions:

Diffuse AstrocytomaAnaplastic AstrocytomaAstrocytomaOligodendroglioma, ChildhoodAnaplastic OligodendrogliomaGlioblastomaPilocytic AstrocytomaGiant Cell AstrocytomaPleomorphic XanthoastrocytomaAnaplastic Pleomorphic XanthoastrocytomaAngiocentric GliomaChordoid Glioma of Third VentricleGangliocytomaGangliogliomaAnaplastic GangliogliomaDysplastic Gangliocytoma of CerebrellumDesmoplastic Infantile Astrocytoma and GangliogliomaPapillary Glioneuronal TumorRosette-forming Glioneuronal TumorCentral NeurocytomaExtraventricular NeurocytomaCerebellar LiponeurocytomaNeurofibromatosis Type 1

Study Overview

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Study Details

Study overview

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

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

Pediatric Long-Term Follow-up and Rollover Study

Condition
Diffuse Astrocytoma
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children s Hospital, Phoenix, Arizona, United States, 85016

Washington

Childrens National Hospital, Washington, District of Columbia, United States, 20010

Miami

Nicklaus Childrens Hospital, Miami, Florida, United States, 33155

Indianapolis

Indiana Uni School of Medicine, Indianapolis, Indiana, United States, 46202-2810

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Cincinnati

Cinn Children Hosp Medical Center, Cincinnati, Ohio, United States, 45229-3039

Memphis

St Jude Childrens Research Hospital, Memphis, Tennessee, United States, 38105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

1 Year to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2026-07-23