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NCT05717153

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

StatusRecruiting
PhaseEarly Phase 1
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 1 month later.

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Record History

All 11 versions: 9 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Feb 29, 2028 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Start date: Oct 1, 2023 to Sep 15, 2023
    • Eligibility criteria shortened, about 29 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site contact updated
  2. Eligibility criteria expanded, about 3 wordsv10
  3. Enrollment target: 15 to 18
    • Eligibility criteria expanded, about 3 words
    v9
  4. Site contact updatedv7
  5. Start date: Aug 28, 2023 to Oct 1, 2023v6
Show 3 earlier versionsHide 3 earlier versions
  1. Interventions: Biospecimen Collection (Procedure), Computed Tomography (Procedure), Eflornithine (Drug), Magnetic Resonance Imaging (Procedure), Polyamine… to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Eflornithine (Drug), Magnetic Resonance Imaging (Procedure)…v5 Show 4 more changesShow less
    • Secondary endpoints revised (6)
    • Study description expanded, about 43 words
    • Site contact updated
    • Eligibility criteria shortened, about 1 word
  2. Primary completion date: Jan 15, 2025 to Jan 15, 2027
    • Start date: Mar 1, 2023 to Aug 28, 2023
    • Study completion date: Jan 15, 2026 to Sep 15, 2027
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 15, 2023 to Mar 1, 2023
    • Interventions: Biospecimen Collection (Procedure), Computed Tomography (Procedure), Eflornithine (Drug), Magnetic Resonance Imaging (Procedure), Placebo… to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Eflornithine (Drug), Magnetic Resonance Imaging (Procedure), Polyamine…
    • Site details revised
    v3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change in the tumor/brain extracellular guanidinoacetate ratio
Timeframe: Baseline up to 2 months

Secondary (6)

Measured extracellular levels of glutamate in tumor and brain microdialysates
Proportion of longitudinal microdialysis aliquots containing > 30 uL of microdialysate
Central nervous system free drug levels from microdialysate - DFMO
Central nervous system free drug levels from microdialysate - AMXT 1501
AMXT 1501 brain/plasma ratio over time
Show 1 moreShow less
Incidence of adverse events

Arms and interventions

Arm I (MRI, resection, DFMO, AMXT 1501)Experimental

Patients undergo magnetic resonance imaging (MRI) and surgical resection at baseline. Patients receive eflornithine PO in combination with AMXT 1501 PO on days 1-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.

Arm II (MRI, resection, placebo, DMFO, AMXT 1501)Placebo comparator

Patients undergo magnetic MRI and surgical resection at baseline. Patients receive placebo PO on days 1 and 2 post-surgery, and then receive eflornithine PO and AMXT 1501 PO on days 3-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.

Arm III (MRI, resection, DMFO, AMXT 1501)Active comparator

Patients undergo magnetic MRI and surgical resection at baseline. Patients receive eflornithine PO alone on days 1 and 2 post-surgery, then receive eflornithine PO in combination with AMXT 1501 PO on days 3-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.

Procedures: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Resection, Placement

Drugs: Eflornithine, Polyamine Transport Inhibitor AMXT-1501 Dicaprate

Devices: Microdialysis

Sites

1 site in 1 country

  • Mayo Clinic in RochesterRochester, Minnesota, United States