Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK

Sponsor
St. Justine's Hospital
Study ID
NCT06666348
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Pediatric Low-grade Glioma

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirdametinib — DRUG
    Participants will receive orally administered mirdametinib in combination with intravenous vinblastine chemotherapy

Study Details

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 Dates

First listed
Oct 30, 2024
Start date
Jan 12, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2033

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mirdametinib + IV Vinblastine
    Patients will receive oral mirdametinib twice daily (continuous) at a fixed dose (2mg/m2 PO BID, rounded to the nearest 1mg, up to a maximum of 4 mg BID) for a total of 13 cycles. Each cycle will last 28 days.

Primary Outcome Measure

Determine maximum tolerated dose of Mirdametinib plus Vinblastine. [ Time Frame: 3 years ]

Central Contacts