Health Trials

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

ConditionsHigh Grade GliomaCNS Tumor
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Entrectinib

    Drug

    Given orally (PO) or enterally

  • Cyclophosphamide

    Drug

    Given intravenous (IV)

  • Etoposide

    Drug

    Given IV

  • Carboplatin

    Drug

    Given IV

  • G-CSF

    Biological/Vaccine

    Given subcutaneous (SQ) or IV

  • Pegfilgrastim

    Biological/Vaccine

    Given SQ as part of recommended Bridging Therapy instead of G-CSF.

  • Surgery

    Procedure/Surgery

    A gross total resection or significant debulking may become possible if a response to entrectinib is seen.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Entrectinib therapy, Cohort 1 and Cohort 2Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR) (Cohort 1)

ORR is defined as the percentage of patients with either partial or complete response assessed at the protocol-defined evaluation timepoint. Overall response will be determined by the central imaging review based on the scheduled evaluations.

Time frame
After cycle 4 (each cycle is 28 days).

Secondary outcomes

1

Progression free survival (PFS) (Cohort 1)

PFS is defined as the time from initiation of protocol treatment to first event (progressive disease, death due to any cause), or date last follow-up among those who have not had an event. Described using Kaplan Meier method.

Time frame
At 2 and 5 years
2

Overall survival (OS) (Cohort 1)

OS is defined as the time from date of diagnosis to date of death due to any cause or date last follow-up. Described using Kaplan Meier method.

Time frame
At 2 and 5 years
3

Duration of response (DOR) (Cohort 1)

DOR is defined as time from date of first response (partial or complete) until the date of progression or last follow-up. Described as median time.

Time frame
Up to 5 years
4

Patients who have second surgeries (Cohort 1)

Percentage of patients who had second surgeries.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Jude Children's Research Hospital

Lead sponsor

Hoffmann-La Roche

Collaborator

Source ClinicalTrials.gov
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