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NCT05634707 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)
A Early Phase 1 study of Primary Brain Tumor and Brain Tumor, Recurrent, sponsored by Duke University.
- Active
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 4
- Study locations
NCT05634707: Active Early Phase 1 study of Primary Brain Tumor and Brain Tumor, Recurrent, sponsored by Duke University.
NCT05634707 is a Early Phase 1 study of Primary Brain Tumor and Brain Tumor, Recurrent that is active but no longer recruiting, run by Duke University. The registered enrollment target is 10 participants, below the 84-participant average among 7 other Primary Brain Tumor trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05634707, a Early Phase 1 study of Primary Brain Tumor and Brain Tumor, Recurrent, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this research study is to determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery. Lysosomes are organelles (structures in cells) that contain digestive enzymes (substances that break down chemicals) that help keep the cells free of extra or worn out cell parts. Fluoxetine, a drug approved by the FDA to treat problems like depression and anxiety, can cause changes to structures in cells called lysosomes that then improve how well the chemotherapy drug temozolomide (TMZ) kills cancer cells in the brain.
Primary Outcome
Determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained during surgery or biopsy
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Fluoxetine
Study Locations (4)
California
- UC San Diego Moores Cancer Center - San Diego
- Stanford Cancer Institute - Stanford
New York
- NYU Langone Health - New York
North Carolina
- The Preston Robert Tisch Brain Tumor Center at Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-08-05 |
| Est. Completion | 2027-06-05 |
| Phase | Early Phase 1 |
What the registry record for NCT05634707 still lists
NCT05634707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 84-participant average among 7 other Primary Brain Tumor trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Primary Brain Tumor appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT05634707 reports a single indexed study location in California, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05634707 about?
NCT05634707 is a clinical study titled "Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)". The purpose of this research study is to determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery. Lysosomes are organelles (structures in cells) that contain digest...
What is the current status of trial NCT05634707?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2023-08-05. Estimated completion is 2027-06-05.
What conditions does trial NCT05634707 study?
This clinical trial studies the following conditions: Primary Brain Tumor, Brain Tumor, Recurrent.
What interventions are being tested in trial NCT05634707?
The interventions under investigation include: Temozolomide (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT05634707?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05634707 being conducted?
This trial has 4 study locations across California, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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