OncoMatch/Clinical Trials/NCT04655404
A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion
Is NCT04655404 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies Larotrectinib for high grade glioma.
Treatment: Larotrectinib — This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Biomarker criteria
Required: NTRK1 fusion
Required: NTRK2 fusion
Required: NTRK3 fusion
Demographics
Prior therapy
Cannot have received: investigational drug
Patients who have previously received or are currently receiving another investigational drug are not eligible.
Cannot have received: anti-cancer agents
Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3; Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment); Hemoglobin >8 g/dL (may receive transfusions)
Kidney function
Serum creatinine within normal institutional limits, or Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2
Liver function
Total bilirubin ≤ 2.5 × institutional upper limit of normal; AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
Adequate Bone Marrow Function ... Adequate Renal Function ... Adequate Liver Function ... Adequate Pulmonary Function Defined as: Pulse oximetry > 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
- Children's National Medical Center · Washington D.C., District of Columbia
- Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, Illinois
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Duke University Health System · Durham, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04655404 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require NTRK1?
Yes, NTRK1 fusion is a required biomarker for enrollment.
Does this trial require NTRK2?
Yes, NTRK2 fusion is a required biomarker for enrollment.
Does this trial require NTRK3?
Yes, NTRK3 fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify