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Kinase Inhibitor

Larotrectinib for TRK Fusion Cancers and Acute Leukemia

Phase 2

Waitlist Available

Led By Theodore W Laetsch

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must be =< 30 years of age at the time of study entry

COHORT C: Patients must have a histologic diagnosis of relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion identified in a CLIA/CAP certified laboratory

Must not have

Patients receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant

Patients currently receiving a strong CYP3A4 inducer or inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects and effectiveness of larotrectinib in treating patients with solid tumors or acute leukemia that have a specific genetic mutation (TRK fusion). Larotrectinib may stop the growth of cancer cells by blocking the TRK enzymes needed for cell growth.

Who is the study for?

This trial is for patients under 30 with untreated TRK fusion solid tumors or relapsed acute leukemia. They must have no prior cancer treatment except surgery, meet blood and organ function criteria, not be pregnant or breastfeeding, able to swallow capsules or have gastric access, and not on certain medications.

What is being tested?

The study tests Larotrectinib's effectiveness in blocking TRK enzymes to stop cancer cell growth in those with specific genetic markers (NTRK1, NTRK2, NTRK3 fusions). It includes young patients who haven't tried other treatments and whose disease has measurable indicators of progress.

What are the potential side effects?

While the trial primarily investigates efficacy, potential side effects may include issues related to enzyme inhibition that could affect cell growth regulation. Specific side effects are not listed but would generally relate to the drug's action on cellular pathways.

Eligibility Criteria

Inclusion Criteria

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

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I am 30 years old or younger.

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My leukemia has come back or didn't respond to treatment, and tests show NTRK fusion.

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My nervous system disorder is mild.

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My organs are functioning well.

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I have not had any cancer treatment except for surgery.

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I have never taken TRK inhibitor medications.

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I can do most activities but may need help.

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I have infantile fibrosarcoma with an NTRK fusion confirmed by a certified lab.

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I have recovered from side effects of my previous cancer treatments.

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My tumor, not a high-grade glioma or infantile fibrosarcoma, has an NTRK fusion.

Exclusion Criteria

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

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I am taking medication to prevent rejection after a bone marrow transplant.

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

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I have a condition that severely affects my body's ability to absorb nutrients.

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I have been diagnosed with a high-grade brain tumor.

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I do not have any infections that are currently uncontrolled.

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I cannot swallow pills or liquids and do not have a tube for feeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate (ORR) of children with infantile fibrosarcoma (IFS) treated with neoadjuvant larotrectinib prior to local control

Secondary study objectives

DoR of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control

Duration of response (DoR) of children with IFS treated with neoadjuvant larotrectinib prior to local control

EFS of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (larotrectinib)Experimental Treatment1 Intervention

Patients receive larotrectinib PO or by NG or G-tube BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity, or complete surgical resection of tumor.

0 / 16Eligibility criteria met