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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
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 outcome measures
Ability to detect NTRK fusions in circulating cell-free tumor deoxyribonucleic acid in plasma
Pharmacokinetics of larotrectinib

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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 2
~1720
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Bone Scan
2015
Completed Phase 2
~50
Computed Tomography
2017
Completed Phase 2
~2720
Radionuclide Imaging
2004
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,315 Total Patients Enrolled
Katherine A JanewayPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Larotrectinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03213704 — Phase 2
Langerhans Cell Histiocytosis Research Study Groups: Treatment (larotrectinib sulfate)
Langerhans Cell Histiocytosis Clinical Trial 2023: Larotrectinib Highlights & Side Effects. Trial Name: NCT03213704 — Phase 2
Larotrectinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03213704 — Phase 2
Langerhans Cell Histiocytosis Patient Testimony for trial: Trial Name: NCT03213704 — Phase 2
~2 spots leftby Sep 2024
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