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New treatment option for High Grade Glioma
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
ClinicalTrials.gov ID: NCT06528691
What this study is testing
What is Entrectinib?
Entrectinib is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for high grade glioma.
Also referred to as Rozlytrek.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 3
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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 Exclusion Criteria: COHORT 1 AND 2
- Clinically significant medical disorder that could compromise the ability to tolerate study therapy or would interfere with the study procedures or results history
- History of recent (3 months) symptomatic congestive heart failure
- Known active, uncontrolled infection (bacterial, fungal, or viral)
- Receiving enzyme inducing antiepileptic drugs (EIAEDs)
- Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation
- Receiving another investigational agent concurrently
- Surgery within 2 weeks prior to treatment enrollment
- Patients with known hypersensitivity to excipients of the investigational medicinal product
- Active gastrointestinal disease or malabsorption disorder (e.g. Crohn's disease, ulcerative colitis, short-gut syndrome) that would impair drug absorption
- Inability to take medication enterally
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
- Barretos, São Paulo, Brazil
- São Paulo, Brazil
- Amman, Jordan
- Lima, Peru
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States; Barretos, São Paulo, Brazil; São Paulo, Brazil; Amman, Jordan; Lima, Peru. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.