Condition: Pediatric Low-grade Glioma · Sponsor: St. Justine's Hospital
This is a 3-part open-label study (feasibility phase, treatment phase and follow-up phase) of orally administered mirdametinib in combination with intravenous vinblastine chemotherapy in patients with PLGG with activation of MAPK pathway. Feasibility Phase: The maximum tolerated/recommended phase 2 dose (MTD/RP2D) of the mirdametinib plus vinblastine combination will be assessed using a modified Rolling-6 design. Treatment Phase: Patients will receive mirdametinib twice daily (continuously) at a fixed dose (2mg/m2 po BID up to 4 mg BID) for a total of 13 cycles (28 days cycle). Weekly intravenous vinblastine at MTD will be given for a total of 17 cycles. If adverse events occur, two dose reductions are allowed. Follow-up Phase: Following the end of treatment, patients will be scheduled for a follow-up visit every 6 months for 36 months to evaluate PFS, TTP and OS.
This description comes directly from the study's public registry record.
Sébastien Perreault, M.D, FRCPC · 514-345-4931 · s.perreault@umontreal.ca
MIRV Study Team · mirv.study.hsj@ssss.gouv.qc.ca
Always discuss trial participation with your own doctor first.
| Alberta Children's Hospital | Calgary, Alberta, Canada | Recruiting |
| Stollery Children's Hospital | Edmonton, Alberta, Canada | Recruiting |
| Childrens and Womens Health Centre of British Columbia - British Columbia Childrens Hospital | Vancouver, British Columbia, Canada | Recruiting |
| Children's Hospital, London Health Sciences Centre | London, Ontario, Canada | Recruiting |
| The Hospital for Sick Children | Toronto, Ontario, Canada | Recruiting |
| CHU Sainte-Justine | Montreal, Quebec, Canada | Recruiting |
| CHU de Québec - Université Laval | Québec, Quebec, Canada | Recruiting |
| CHU de Sherbrooke | Sherbrooke, Quebec, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06666348