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Kinase Inhibitor

Larotrectinib for Advanced Cancer

Phase 2

Waitlist Available

Led By Katherine A Janeway

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must not have received prior exposure to other NTRK inhibitors including but not limited to LOXO-101 (larotrectinib), entrectinib (RXDX-101), DS6051, PLX7486

Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)

Must not have

Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible

Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease (GVHD) post bone marrow transplant are not eligible for this trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing larotrectinib, which may stop the growth of cancer cells, in patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread and come back or do not respond to treatment.

Who is the study for?

This trial is for young patients aged 12 months to 21 years with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have NTRK fusions and are relapsed or refractory. They must not have used other NTRK inhibitors before, should be recovered from previous cancer treatments' side effects, and meet specific health criteria like adequate kidney function and blood counts.

What is being tested?

The study tests larotrectinib's effectiveness on various advanced cancers in youth with a genetic change called an NTRK fusion. It examines if this drug can halt cancer growth by blocking enzymes needed for cell proliferation. The trial includes imaging tests like MRI and CT scans to monitor the disease.

What are the potential side effects?

Larotrectinib may cause liver issues (elevated bilirubin), impact kidney function (creatinine clearance), affect blood cell counts leading to increased infection risk, fatigue, or other common chemotherapy-related side effects. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I have not taken any NTRK inhibitor medications.

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My bilirubin levels are within the normal range for my age.

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My white blood cell count is healthy.

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My kidney function test shows a clearance rate of at least 70 ml/min.

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I am mostly able to care for myself and carry out daily activities.

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I am enrolled in APEC1621SC and assigned to MATCH for an actionable mutation.

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I am between 12 and 21 years old.

Exclusion Criteria

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

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I am not taking medication that strongly affects liver enzyme CYP3A4.

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I am not taking medication to prevent GVHD after a bone marrow transplant.

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I have been on a stable or decreasing dose of corticosteroids for at least 7 days.

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I do not have any infections that are not under control.

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I have not taken TRK inhibitors like entrectinib for my condition.

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

Secondary study objectives

Percentage of Participants With Treatment-related Adverse Events as Accessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0

Progression free survival

Other study objectives

Ability to detect NTRK fusions in circulating cell-free tumor deoxyribonucleic acid in plasma

Pharmacokinetics of larotrectinib

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 sulfate)Experimental Treatment8 Interventions

Patients receive larotrectinib sulfate PO or via NG- or G-tube BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, an x-ray, bone scan, and/or MIBG scintigraphy during screening and on study. Patients also undergo bone marrow aspiration and/or biopsy during screening and may undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration and Biopsy

2016

Completed Phase 1

~40

Bone Scan

2015

Completed Phase 2

~50