Trials / Active Not Recruiting

Active Not RecruitingNCT03213704

Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 (Larotrectinib) in Patients With Tumors Harboring Actionable NTRK Fusions

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 9 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 12 Months – 21 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with larotrectinib sulfate (LOXO-101 \[larotrectinib\]) with advanced solid tumors (including central nervous system \[CNS\] tumors), non-Hodgkin lymphomas or histiocytic disorders harboring NTRK 1/2/3 fusions. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders with NTRK 1/2/3 fusions. II. To obtain additional information about the tolerability of LOXO-101 (larotrectinib) in children with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics of LOXO-101 (larotrectinib) in children with relapsed or refractory cancer. EXPLORATORY OBJECTIVE: I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive larotrectinib sulfate orally (PO) or via nasogastric (NG)- or gastric (G)-tube twice per day (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 computed tomography (CT) scan, magnetic resonance imaging (MRI), an x-ray, bone scan, and/or iobenguane (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. After completion of study treatment, patients are followed up at 30 days, then periodically thereafter.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration and Biopsy	Undergo a bone marrow aspiration and/or biopsy
PROCEDURE	Bone Scan	Undergo a bone scan
PROCEDURE	Computed Tomography	Undergo a CT scan
DRUG	Larotrectinib Sulfate	Given PO or via nasogastric- or gastric-tube
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Radionuclide Imaging	Undergo a MIBG scintigraphy
PROCEDURE	X-Ray Imaging	Undergo an x-ray

Timeline

Start date: 2017-08-23
Primary completion: 2024-09-30
Completion: 2026-10-08
First posted: 2017-07-11
Last updated: 2025-12-03
Results posted: 2025-10-16

Locations

124 sites across 2 countries: United States, Puerto Rico

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03213704. Inclusion in this directory is not an endorsement.