Pediatric Long-Term Follow-up and Rollover Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03975829
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
1 Year - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 4, 2019
Status verified
Jun 2026
Primary completion
Nov 5, 2026
Completion
Nov 5, 2026

Study Design

Enrollment
165 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib and/or trametinib
    Patients in this study may receive one of the following treatments received in the parent study which are: * Patients who received monotherapy of either of dabrafenib or trametinib * Patients who received combination of dabrafenib and trametinib * Patients who discontinued treatment on parent study are still offered to participate in long-term follow-up

Primary Outcome Measure

Number of participants with Adverse Events and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 7 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Phoenix Children s HospitalPhoenixArizona85016-
Childrens National HospitalWashington D.C.District of Columbia20010-
Nicklaus Childrens HospitalMiamiFlorida33155-
Indiana Uni School of MedicineIndianapolisIndiana46202-2810-
Johns Hopkins HospitalBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of MinnesotaMinneapolisMinnesota55455-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Cancer CtrNew YorkNew York10065-
Cinn Children Hosp Medical CenterCincinnatiOhio45229-3039-
St Jude Childrens Research HospitalMemphisTennessee38105-
Texas Childrens HospitalHoustonTexas77030-

Find similar trials in Phoenix, AZ

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Phoenix Children s Hospital· Phoenix, AZChildrens National Hospital· Washington D.C., DCNicklaus Childrens Hospital· Miami, FLIndiana Uni School of Medicine· Indianapolis, INJohns Hopkins Hospital· Baltimore, MDDana Farber Cancer Institute· Boston, MA

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