Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 3
SponsorSt. Jude Children's Research Hospital

About this trial

This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

Eligibility criteria

Qualifiers

Age from birth to age <3 years at the time of diagnosis (date of surgical resection/biopsy)

Participant with presumed newly diagnosed tumor in the supratentorial compartment

Patient must have measurable disease based on RAPNO criteria

≤84 days since surgery (resection or biopsy)

Disqualifiers

Previous exposure to cytotoxic chemotherapy or radiotherapy

Patients must be <3 years of age at the time of diagnosis (date of surgical resection/biopsy)

High-grade glioma (World Health Organization [WHO] grade III or IV) harboring NTRK1/2/3 or ROS1 gene fusions as determined by central pathology review

Patients must have measurable disease as defined by RAPNO criteria

Trial design

Treatments tested in this trial

  • Entrectinib
  • Cyclophosphamide
  • Etoposide
  • Carboplatin
  • G-CSF
  • Pegfilgrastim
  • Surgery

Treatment groups

52 Participants
are divided into 1 treatment group

Locations

6
Brazil
Hospital de Câncer de Barretos14784400, BarretosSão Paulo, Brazil
GRAACC Hospital (Grupo de Apoio ao Adolescente e à Criança com Câncer)04039-001, São Paulo Brazil
Hospital Santa Marcelina08270-070, São Paulo Brazil
Jordan
King Hussein Cancer Center11941, Amman Jordan

Sponsors and collaborators

St. Jude Children's Research Hospital

Lead sponsor

Hoffmann-La Roche

Collaborator