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Kinase Inhibitor

Larotrectinib for Brain Cancer (CONNECT1903 Trial)

Phase < 1

Recruiting

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with disseminated DIPG or HGG are eligible only if receiving chemotherapy only, with no craniospinal RT intended

Patients with primary spinal tumors are eligible only if receiving either chemotherapy or focal radiation therapy, with no craniospinal RT intended

Must not have

Patients who have previously received or are currently receiving other anti-cancer agents

Patients with active, uncontrolled systemic bacterial, viral or fungal infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn more about how well larotrectinib works in children with glioma that have a TRK fusion, as well as the safety of the medication.

Who is the study for?

This trial is for children up to 21 years old with a specific type of brain tumor called high-grade glioma that has NTRK fusion. They must not have had cancer treatment before and should be healthy enough for chemotherapy or radiation, based on certain medical criteria. Pregnant individuals or those who've taken other experimental drugs are excluded.

What is being tested?

The study tests Larotrectinib's effects after two cycles in treating newly-diagnosed high-grade gliomas with NTRK fusion in children. It examines the drug's safety alongside chemotherapy and after focal radiation therapy.

What are the potential side effects?

While the trial aims to assess Larotrectinib's safety, potential side effects may include liver issues, fatigue, dizziness, nausea, vomiting, constipation, anemia and risk of infections due to weakened immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have DIPG or HGG and am only receiving chemotherapy, with no plans for craniospinal radiation.

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I have a spinal tumor and am receiving chemotherapy or targeted radiation, but not full spine radiation.

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My high-grade brain tumor has a specific genetic change called NTRK fusion.

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I am 21 years old or younger.

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I am mostly able to care for myself, regardless of my age.

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My brain tumor is a high-grade type like glioblastoma.

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I have a high-grade glioma with NTRK fusion and need more surgery after my biopsy.

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I have not had chemotherapy for cancer before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking or have taken cancer treatment drugs.

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I do not have any active, uncontrolled infections.

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I have a condition that affects how my body absorbs medication taken by mouth.

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I am currently taking medication that strongly affects liver enzyme CYP3A4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease control rate

Maximum Plasma Concentration [Cmax] of larotrectinib

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

+1 more

Secondary study objectives

Objective response rate (ORR)

Survival rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Surgical CohortExperimental Treatment2 Interventions

Larotrectinib administered PO, BID @100 mg/m2 3-5 days prior to definitive surgery, followed by Larotrectinib administered PO, BID @100 mg/m2 on a 28-day cycle schedule.

Group II: Feasibility CohortExperimental Treatment1 Intervention

Larotrectinib administered PO, BID @100 mg/m2 on a 28-day cycle schedule.

0 / 12Eligibility criteria met