LOXO-TRK-15003 (solid/CNS tumors)
Active, not recruiting
Who can enter
Children and adolescents with advanced or metastatic infantile fibrosarcoma, a brain tumor, or another solid tumor in whom the disease has returned (relapsed) or responded insufficiently to treatment (refractory). They must have a documented NTRK gene abnormality in the tumor
Age: up to 21 years
Goal
Goal
The goal of this study is to evaluate the safety and efficacy of larotrectinib in children and adolescents. We will assess which side effects occur due to the treatment, and to what extent and how long the tumor responds to the treatment.
Background
Background
NTRK gene abnormalities are rare, and occur in different tumor types, both in children and adults. Among others, this abnormality has been found in children with infantile fibrosarcoma, some brain tumors, thyroid carcinoma, and certain forms of melanoma.
The NTRK gene abnormality results in the production of an aberrant TRK protein, a so-called tyrosine kinase. This enables tumor cells to grow and proliferate. The drug larotrectinib selectively inhibits the TRK protein. This type of drug is called a tyrosine kinase inhibitor (TKI).
In previous clinical studies larotrectinib was found to be safe, and resulted in a good response in many patients. Based on these results, larotrectinib has been granted accelerated approval for the treatment of adults and children with solid tumors carrying an NTRK gene abnormality, who have no other suitable treatment options. However, additional data are needed to be able to properly assess the efficacy and safety.
This study is now closed for inclusion.
Last reviewed
Last reviewed
March 23, 2026
Study details
- Study details
Official title
A phase 1/2 study of the oral TRK inhibitor larotrectinib in pediatric patients with advanced solid or primary central nervous system tumorsCancer type
Infantile fibrosarcoma with NTRK gene abnormality
Primary central nervous system (CNS) tumors with NTRK gene abnormality
Other solid tumors with NTRK gene abnormality
Phase
1/2Maximum number of patients
162, of whom 3 are expected to participate in the NetherlandsStart date
September 25, 2018Status
Closed for inclusionLocal principal investigator
Prof. dr. C.M. ZwaanSponsor
Bayer Consumer Care AG, Basel, SwitzerlandApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
EudraCT number 2016-003498-16
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.