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| Diagnosis | ALK Fusion-positive Solid or CNS Tumors | Study Status | Open |
| Phase | I/II |
| Age | up to 17 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Alectinib: taken by mouth twice daily
|
| Last Posted Update | 2024-03-15 |
| ClinicalTrials.gov # | NCT04774718 |
International Sponsor
Hoffmann-La RochePrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
CHU Ste Justine - Dr. Nicholas Prud'hommeCentres
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
Study Description
In this study, researchers are trying to learn more about how safe the study medicine called Alectinib is, and how well they work for children and young people with certain solid or brain cancers where previous treatment has not worked or is not available.
Inclusion Criteria
- Patients must have a confirmed diagnosis of a brain tumour or solid tumor with a specific gene change called "ALK fusion"
- Patients must have a cancer that has come back (relapsed) or has no standard treatment available
- Patients must be 17 years old or younger to participate
- Patients must be able to walk and do routine activities for more than half of their normal waking hours
- Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)
Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.
