Actively Recruiting
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
Led by St. Jude Children's Research Hospital · Updated on 2026-05-13
52
Participants Needed
6
Research Sites
339 weeks
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from birth to less than 3 years at diagnosis
- Newly diagnosed tumor in the brain's supratentorial area
- Measurable disease based on RAPNO criteria
- Surgery (resection or biopsy) done within 84 days before screening
- Available tumor tissue for central review
- Parent or guardian able and willing to provide informed consent
- For Cohort 1: High-grade glioma (WHO grade III or IV) with NTRK1/2/3 or ROS1 gene fusions
- For Cohort 2: CNS tumor other than high-grade glioma with NTRK1/2/3 or ROS1 gene fusions
- Eligible at diagnosis before any chemotherapy, targeted therapy, immunotherapy, cellular therapy, or radiation
- Screening within 28 days before study start
- Lansky performance score 50% or higher and life expectancy of at least 12 weeks
- Stable neurological deficits for at least 7 days before enrollment
- Adequate blood counts: hemoglobin ≥ 8 g/dL, platelets ≥ 75,000/μL, neutrophils > 1,000/μL without recent transfusions
- Liver function tests: AST and ALT ≤ 2.5 times upper limit of normal; bilirubin ≤ 1.5 times upper limit
- Adequate kidney function with age-based serum creatinine limits
- Adequate heart function with ECG QTc ≤ 450 ms and echocardiogram LVEF > 50%
- Willingness and ability to follow treatment plan and study procedures
You will not qualify if you...
- Previous chemotherapy or radiotherapy before screening
- Clinically significant medical disorder affecting treatment or study participation
- Recent (within 3 months) symptomatic congestive heart failure
- Known active, uncontrolled infection
- Use of enzyme-inducing antiepileptic drugs
- Prior cancer therapies including chemotherapy (except bridging), targeted therapy, immunotherapy, cellular therapy, or radiation
- Receiving another investigational drug at the same time
- Surgery within 2 weeks before starting treatment
- Known allergy to study medications or their ingredients
- Active gastrointestinal disease or malabsorption that would affect drug absorption
- Inability to take medication by mouth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
2
Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil, 14784400
Actively Recruiting
3
GRAACC Hospital (Grupo de Apoio ao Adolescente e à Criança com Câncer)
São Paulo, Brazil, 04039-001
Actively Recruiting
4
Hospital Santa Marcelina
São Paulo, Brazil, 08270-070
Actively Recruiting
5
King Hussein Cancer Center
Amman, Jordan, 11941
Actively Recruiting
6
Instituto Nacional de Enfermedades Neoplásicas
Lima, Peru
Actively Recruiting
Research Team
T
Tabatha E. Doyle, RN
CONTACT
D
Daniel Moreira, MD, MEd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here