Larotrectinib for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+130 other locations

Overseen byKatherine A Janeway

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and have come back (relapased) or does not respond to treatment (refractory). Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

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.

Inclusion Criteria

All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

I have not taken any NTRK inhibitor medications.

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

+7 more

Exclusion Criteria

Patients who have received a prior solid organ transplantation are not eligible

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

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

+7 more

Participant Groups

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.

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.

Larotrectinib is already approved in United States, European Union, Australia for the following indications:

🇺🇸 Approved in United States as Vitrakvi for: