NCT03213704|Active Not RecruitingPhase 2ResultsFDA Drug

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

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2017-01264APEC1621AU10CA180886

Study Type

interventional

Target

Locations

2 countries

Sites

124

Timeline

RegisteredJul 2017

StartedAug 2017

CompletionOct 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

4mo left

Started Aug 2017

Longer than P75 for phase_2

Geographic Reach

2 countries

124 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.1 years study duration

Study Progress97%

Aug 2017Oct 2026

First Submitted

Initial submission to the registry

July 10, 2017

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

August 23, 2017

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

October 16, 2025

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2026

Expected

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

7.1 years

First QC Date

July 10, 2017

Results QC Date

September 29, 2025

Last Update Submit

May 30, 2026

Conditions

Advanced Malignant Solid Neoplasm Recurrent Glioma Recurrent Hepatoblastoma Recurrent Kidney Wilms Tumor Recurrent Rhabdoid Tumor Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Refractory Langerhans Cell Histiocytosis Refractory Neuroblastoma Refractory Osteosarcoma Refractory Rhabdoid Tumor Refractory Rhabdomyosarcoma Refractory Soft Tissue Sarcoma Recurrent Ependymoma Recurrent Langerhans Cell Histiocytosis Recurrent Malignant Germ Cell Tumor Recurrent Malignant Glioma Recurrent Malignant Solid Neoplasm Recurrent Medulloblastoma Recurrent Neuroblastoma Recurrent Non-Hodgkin Lymphoma Recurrent Osteosarcoma Recurrent Rhabdomyosarcoma Recurrent Soft Tissue Sarcoma Refractory Ependymoma Refractory Glioma Refractory Hepatoblastoma Refractory Malignant Germ Cell Tumor Refractory Malignant Glioma Refractory Malignant Solid Neoplasm Refractory Medulloblastoma Refractory Non-Hodgkin Lymphoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Refractory Primary Central Nervous System Neoplasm

Outcome Measures

Primary Outcomes (1)

Objective Response Rate
A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors).
Up to 2 years from study entry

Secondary Outcomes (2)

Progression Free Survival (PFS)
Up to 6 months from study entry
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events
Up to 2 years from study entry

Other Outcomes (2)

Pharmacokinetics of Larotrectinib
Pre-dose, 1, 2, 4, and 6-8 hours after morning dose of day 1 cycle 1 and pre-dose of day 1 cycle 2
Ability to Detect NTRK Fusions in Circulating Cell-free Tumor Deoxyribonucleic Acid in Plasma
Up to 5 years

Study Arms (1)

Treatment (larotrectinib sulfate)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration and BiopsyProcedure: Bone ScanProcedure: Computed TomographyDrug: Larotrectinib SulfateProcedure: Magnetic Resonance ImagingProcedure: Radionuclide ImagingProcedure: X-Ray Imaging

Interventions

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection