Mirdametinib with vinblastine chemotherapy for newly diagnosed PLGG
Official title: Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study is testing a drug taken by mouth, mirdametinib, given together with vinblastine chemotherapy in people with newly diagnosed PLGG.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT06666348
- Stage of testing
- Phase 1/Phase 2
- Conditions studied
- Pediatric Low-grade Glioma
Where it is running
This trial lists 9 sites.
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Alberta
- Alberta Children's Hospital (Calgary)
- Stollery Children's Hospital (Edmonton)
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British Columbia
- Childrens and Womens Health Centre of British Columbia - British Columbia Childrens Hospital (Vancouver)
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Manitoba
- Cancer Care Manitoba (Winnipeg)
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Ontario
- Children's Hospital, London Health Sciences Centre (London)
- The Hospital for Sick Children (Toronto)
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Quebec
- CHU Sainte-Justine (Montreal)
- CHU de Québec - Université Laval (Québec)
- CHU de Sherbrooke (Sherbrooke)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.