Status:
RECRUITING
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
High Grade Glioma
CNS Tumor
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVE * To determine the overall response rate of entrectinib when used as first line therapy in patients who are younger than 3 years of age with NTRK1/2/3- or ROS1-fused high-grade glio...
Eligibility Criteria
Inclusion
- Screening Phase
- 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)
- Available tumor tissue for central review
- Parent/guardian has the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines
Exclusion
- Screening Phase
- Previous exposure to cytotoxic chemotherapy or radiotherapy
- Inclusion Criteria: COHORT 1
- 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
- Patients are eligible at the time of diagnosis, prior to any exposure to chemotherapy, targeted therapy, immunotherapy, cellular therapy or radiation
- ≤28 days since study screening
- Lansky score ≥50% and a minimum life expectancy of ≥ 12 weeks
- Neurologic deficits must have been stable for at least 7 days prior to study enrollment
- Hemoglobin ≥ 8 g/dL (without transfusion or erythropoietin use within 7 days prior to enrollment)
- Platelet count ≥ 75,000/µL (without transfusion within 7-day period prior to enrollment)
- Absolute neutrophil count \>1,000/µL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x the upper limit of normal (ULN)
- Bilirubin ≤ 1.5 x ULN
- Adequate renal function as defined by the following age-based serum creatinine concentrations:
- 0 to \<1 year: 0.5 mg/dL
- 1 to \<2 years: 0.6 mg/dL
- 2 to 3 years: 0.8 mg/dL
- Adequate cardiac function as defined by electrocardiogram (ECG) with Fridericia's corrected QT interval (QTc) ≤ 450 msec and echocardiogram left ventricular ejection fraction (LVEF) \>50%
- Screening and enrollment consents signed
- Willingness and ability to comply with treatment plan, scheduled visits, laboratory tests and other study procedures
- Inclusion Criteria: COHORT 2
- Patients must be \<3 years of age at the time of diagnosis (date of surgical resection/biopsy)
- CNS tumor other than HGG harboring NTRK1/2/3 or ROS1 gene fusions as determined by central pathology review
- Patients must have measurable disease as defined by RAPNO criteria
- Patients are eligible at the time of diagnosis, prior to any exposure to chemotherapy, targeted therapy, immunotherapy, cellular therapy or radiation
- ≤28 days since study screening
- Lansky score ≥50% and a minimum life expectancy of ≥ 12 weeks
- Neurologic deficits must have been stable for at least 7 days prior to study enrollment.
- Hemoglobin ≥ 8 g/dL (without transfusion or erythropoietin use within 7 days prior to enrollment)
- Platelet count ≥ 75,000/µL (without transfusion within 7-day period prior to enrollment);
- Absolute neutrophil count \>1,000/µL.
- ALT and ALT ≤2.5x the upper limit of normal (ULN)
- Bilirubin ≤ 1.5 x ULN
- Adequate renal function as defined by the following age-based serum creatinine concentrations:
- 0 to \<1 year: 0.5 mg/dL
- 1 to \<2 years: 0.6 mg/dL
- 2 to 3 years: 0.8 mg/dL
- Adequate cardiac function as defined by ECG with QTc ≤ 450 msec and echocardiogram LVEF \>50%
- Screening and enrollment consents signed
- Willingness and ability to comply with treatment plan, scheduled visits, laboratory tests and other study procedures
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06528691
Start Date
January 1 2026
End Date
November 1 2032
Last Update
November 28 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105