ACTIVE_NOT_RECRUITING

Pediatric Long-Term Follow-up and Rollover Study

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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 1v600-mutationneuroblastomaTrametinibpediatricsLangerhans Cell Histiocytosislow grade gliomaplexiform neurofibromashigh grade gliomadabrafenibNF-1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2019-11-04
Study Completion:2026-11-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03975829

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.

Ages Eligible for Study:1 Year to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participation in a Novartis sponsored study such as CTMT212X2101, CDRB436G2201, CDRB436A2102, regardless of current age.
  3. * Parent study (or cohort of parent study) is planned to be closed.
  4. * Subject has demonstrated compliance, as assessed by the investigator, within the parent study protocol requirement(s).
  5. * Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
  6. * 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
  7. * In the opinion of the investigator is likely to benefit from continued treatment.
  1. * Subject has permanently discontinued from study treatment in the parent protocol due to any reason.
  2. * 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
  3. * 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.

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Phoenix Children s Hospital
Phoenix, Arizona, 85016
United States
Childrens National Hospital
Washington D.C., District of Columbia, 20010
United States
Nicklaus Childrens Hospital
Miami, Florida, 33155
United States
Indiana Uni School of Medicine
Indianapolis, Indiana, 46202-2810
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065
United States
Cinn Children Hosp Medical Center
Cincinnati, Ohio, 45229-3039
United States
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
United States
Texas Childrens Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

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

Study Start Date2019-11-04
Study Completion Date2026-11-06

Study Record Updates

Study Start Date2019-11-04
Study Completion Date2026-11-06

Terms related to this study

Keywords Provided by Researchers

  • v600-mutation
  • neuroblastoma
  • Trametinib
  • pediatrics
  • Langerhans Cell Histiocytosis
  • low grade glioma
  • plexiform neurofibromas
  • high grade glioma
  • dabrafenib
  • NF-1

Additional Relevant MeSH Terms

  • 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 Glioneuronal Tumor
  • Central Neurocytoma
  • Extraventricular Neurocytoma
  • Cerebellar Liponeurocytoma
  • Neurofibromatosis Type 1