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Kinase Inhibitor

Larotrectinib for Brain Cancer (CONNECT1903 Trial)

Q: Is this clinical trial taking place at multiple facilities across Canada?

There are 15 sites enrolling patients in this trial, with the primary locations being Dana-Farber <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Institute in Boston, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>, Cincinnati Children's Hospital Medical Center in Cincinnati, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>, and Children's National Medical Center in <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>, District of Columbia.

Q: How many patients are part of this clinical trial?

That is correct, the clinical trial indicated on clinicaltrials.gov is actively recruiting patients. The original posting was on April 8th, 2021 and was updated as recently as August 10th, 2022. They are looking for a total of 15 patients from 12 different locations.

Q: Are there any available positions for volunteers in this clinical trial?

Yes, the data on clinicaltrials.gov suggests that this clinical trial is currently seeking candidates. The clinical trial was initially posted on 4/8/2021 and was most recently updated on 8/10/2022. The study is searching for 15 patients across 12 sites.

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

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

CONNECT1903 Trial 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.Check my eligibility

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.See study design

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.

CONNECT1903 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

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

Select...

I am 21 years old or younger.

Select...

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

Select...

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

Select...

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

Select...

I have not had chemotherapy for cancer before.

CONNECT1903 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Objective response rate (ORR)

Survival rate

CONNECT1903 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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,491 Total Patients Enrolled

Maryam FouladiStudy ChairNationwide Children's Hospital

9 Previous Clinical Trials

498 Total Patients Enrolled

Susan Chi, MDStudy ChairDana Farber/ Boston Children's Cancer and Blood Disorders Center

2 Previous Clinical Trials

64 Total Patients Enrolled

Media Library

Larotrectinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04655404 — Phase < 1

Brain Tumor Research Study Groups: Feasibility Cohort, Surgical Cohort

Brain Tumor Clinical Trial 2023: Larotrectinib Highlights & Side Effects. Trial Name: NCT04655404 — Phase < 1

Larotrectinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04655404 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial taking place at multiple facilities across Canada?

"There are 15 sites enrolling patients in this trial, with the primary locations being Dana-Farber Cancer Institute in Boston, Massachusetts, Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio, and Children's National Medical Center in Washington, District of Columbia."

Answered by AI

How many patients are part of this clinical trial?

"That is correct, the clinical trial indicated on clinicaltrials.gov is actively recruiting patients. The original posting was on April 8th, 2021 and was updated as recently as August 10th, 2022. They are looking for a total of 15 patients from 12 different locations."

Answered by AI

Are there any available positions for volunteers in this clinical trial?

"Yes, the data on clinicaltrials.gov suggests that this clinical trial is currently seeking candidates. The clinical trial was initially posted on 4/8/2021 and was most recently updated on 8/10/2022. The study is searching for 15 patients across 12 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion

2021. "A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04655404.