SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT04923126
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Low-Grade Glioma
  • Progressive Low-Grade Glioma
  • Recurrent Low-Grade Glioma

Eligibility Criteria

Sex
ALL
Age
2 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirdametinib — DRUG
    By mouth, nasogastric (NG) tube or gastrostomy tube (G-tube) BID, days 1-28

Study Details

This is an open-label, multi-center, Phase 1/2 study of the brain-penetrant MEK inhibitor, mirdametinib (PD-0325901), in patients with pediatric low-grade glioma (pLGG).

Key Dates

Start date
Jun 21, 2021
Status verified
Feb 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
132 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Recurrent and/or progressive low-grade glioma without prior exposure to MEK inhibitors
    Participants will receive mirdametinib at one of the dose levels twice daily days 1-28. For the first cycle of treatment, participants will take mirdametinib tablets dissolved in water. After the first cycle of treatment, participants may receive the medicine the same way (dissolved in water) or may receive capsules. Treatment repeats every 28 days for up to 26 cycles of treatment (24 months) in the absence of disease progression or unacceptable toxicity.
  • Experimental: Phase 2, Cohort 1: Newly diagnosed and/or previously untreated (except surgery)
    Participants will receive the RP2D of mirdametinib. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.
  • Experimental: Phase 2, Cohort 2: Recurrent and/or Progressive without prior exposure to MEK inhibitors
    Participants will receive the RP2D of mirdametinib. Participants may take mirdametinib tablets dissolved in water, or receive capsules. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.
  • Experimental: Phase 2, Cohort 3a:
    Participants with recurrent and/or progressive low-grade glioma who previously received ≥ 6 courses MEK inhibitor (including mirdametinib) and did not progress while on active MEKi therapy. Participants will receive the RP2D of mirdametinib. Participants with previous exposure to mirdametinib may receive a starting dose lower than the RP2D, depending on the dose they tolerated during their previous exposure. Participants may take mirdametinib tablets dissolved in water, or receive capsules. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.
  • Experimental: Phase 2, Cohort 3b:
    Participants with recurrent and/or progressive low-grade glioma who previously received ≥ 6 courses MEK inhibitor (including mirdametinib) and did not progress while on active MEKi therapy. Participants will receive the RP2D of mirdametinib. Participants may take mirdametinib tablets dissolved in water, or receive capsules. Therapy will be administered in cycles of 28 days and may be continued for up to 24 months (26 cycles) in absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Phase 1: Estimate the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of mirdametinib dosed twice daily on a continuous schedule in pediatric patients with progressive or recurrent low-grade glioma. [ Time Frame: 1 month after start of mirdametinib treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Tabatha E. Doyle, RN
[email protected]
901-595-2544
Giles W. Robinson, MD (PRINCIPAL_INVESTIGATOR)
Anna Vinitsky, MD, MS (PRINCIPAL_INVESTIGATOR)

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St. Jude Children's Research Hospital· Memphis, TN

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