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NCT05717153 · ClinicalTrials.gov registry record · Early Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
A Early Phase 1 study of Malignant Glioma and Diffuse Glioma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05717153: Recruiting Early Phase 1 study of Malignant Glioma and Diffuse Glioma, sponsored by Mayo Clinic.
NCT05717153 is a Early Phase 1 study of Malignant Glioma and Diffuse Glioma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 18 participants, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05717153, a Early Phase 1 study of Malignant Glioma and Diffuse Glioma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial studies brain tumor (glioma) metabolism in response to eflornithine (DFMO) and polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) in patients with diffused or high grade glioma. Brain tumors use and produce certain molecules to survive and grow. DFMO is an irreversible inhibitor of ornithine decarboxylase, the enzyme catalyzing polyamine synthesis. AMXT 1501 is a polyamine transport inhibitor which prevents uptake of polyamines from the extracellular environment. This trial is being done to analyze how DFMO and AMXT 1501 affect brain tumor metabolism based on the molecules in the tumor's fluid.
Primary Outcome
Targeted metabolomics will be performed using the microdialysate aliquot collected at each time point to quantify guanidinoacetate content. Fold change values will be calculated between each time point within a patient. Fold changes values between time points will be compared across the three arms for statistically significant differences using a Wilcoxon signed rank test; p \< 0.05 will be considered statistically significant.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Eflornithine
- DRUG Polyamine Transport Inhibitor AMXT-1501 Dicaprate
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2027-09-15 |
| Phase | Early Phase 1 |
What NCT05717153 shows while recruiting
NCT05717153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Malignant Glioma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05717153 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05717153 about?
NCT05717153 is a clinical study titled "Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma". This early phase I trial studies brain tumor (glioma) metabolism in response to eflornithine (DFMO) and polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) in patients with diffused or high grade glioma. Brain tumors use and produce certain molecules to survive and grow. DFMO is an irrever...
What is the current status of trial NCT05717153?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2023-10-01. Estimated completion is 2027-09-15.
What conditions does trial NCT05717153 study?
This clinical trial studies the following conditions: Malignant Glioma, Diffuse Glioma.
What interventions are being tested in trial NCT05717153?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Eflornithine (DRUG), Polyamine Transport Inhibitor AMXT-1501 Dicaprate (DRUG).
Who is sponsoring clinical trial NCT05717153?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05717153 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05717153's enrollment target sits among peer trials
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