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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06528691
Phase
PHASE2
Status
Recruiting
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Conditions

  • CNS Tumor
  • High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
N/A - 3 Years
Healthy Volunteers
Not accepted

Interventions

  • Entrectinib — DRUG
    Given orally (PO) or enterally
  • Cyclophosphamide — DRUG
    Given intravenous (IV)
  • Etoposide — DRUG
    Given IV
  • Carboplatin — DRUG
    Given IV
  • G-CSF — BIOLOGICAL
    Given subcutaneous (SQ) or IV
  • Pegfilgrastim — BIOLOGICAL
    Given SQ as part of recommended Bridging Therapy instead of G-CSF.
  • Surgery — PROCEDURE
    A gross total resection or significant debulking may become possible if a response to entrectinib is seen.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2032

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Entrectinib therapy, Cohort 1 and Cohort 2
    Cohort 1: Patients who are younger than 3 years of age diagnosed with NTRK1/2/3- or ROS1-fused high-grade glioma (HGG) will receive therapy as outline in Detailed Description. Cohort 2: Patients who are younger than 3 years of age diagnosed with NTRK1/2/3- or ROS1-fused CNS tumors other than HGG will receive therapy as outline in Detailed Description.

Primary Outcome Measure

Overall response rate (ORR) (Cohort 1) [ Time Frame: After cycle 4 (each cycle is 28 days). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Tabatha E. Doyle, RN
[email protected]
901-595-2544
[email protected]
Daniel Moreira, MD, MEd (PRINCIPAL_INVESTIGATOR)

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St. Jude Children's Research Hospital· Memphis, TN

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