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| Diagnosis | Infantile fibrosarcoma with TRK fusion, any solid tumour with TRK fusion, any brain tumour with TRK fusion (except high grade glioma), any relapsed acute leukemia with TRK fusion | Study Status | Closed to enrollment |
| Phase | II |
| Age | Child, Adult - (up to 30 Years) | Randomisation | NO |
| Line of treatment | First line treatment, Disease relapse or progression |
| Routes of Treatment Administration | Oral |
| Last Posted Update | 2024-02-12 |
| ClinicalTrials.gov # | NCT03834961 |
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
IWK Health Centre - Dr. Craig Erker
CHU Sainte-Justine - Dr. Yvan Samson
Montreal Children's Hospital – Dr. Sharon AbishCentres
Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez
Dr. Ketan Kulkarni
Social worker/patient navigator contact
Rhonda Brophy
Clinical research contact
Tina Bocking
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Study Description
This clinical trial studies the side effects and how well larotrectinib (a medication taken by mouth) works in treating patients with
- solid tumors and brain tumours with a specific gene change called a "TRK fusion", previously untreated
- acute leukemia that has come back, and has a specific gene change called a "TRK fusion".
Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed for cell growth.
Inclusion Criteria
- Age up to 30 years
- Patients must fit into one of the 3 groups
- Group A: diagnosis of infantile fibrosarcoma with a specific gene change called a "TRK fusion". The patient will have received no prior anti-cancer therapy, including radiotherapy, other than surgical resection (operation to remove the tumour)
- Group B: diagnosis of any solid tumor including brain tumours (except high grade gliomas), with a specific gene change called a "TRK fusion". The patient will have received no prior anti-cancer therapy, including radiotherapy, other than surgical resection (operation to remove the tumour)
- Group C: diagnosis of acute leukemia that has come back, and has a specific gene change called a "TRK fusion".
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
