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NCT05678348 · ClinicalTrials.gov registry record · Early Phase 1
Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated Locally Advanced Head and Neck Squamous Cell Carcinoma
A Early Phase 1 study of Head and Neck Cancer and Cancer of the Head and Neck, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05678348: Completed Early Phase 1 study of Head and Neck Cancer and Cancer of the Head and Neck, sponsored by Washington University School of Medicine.
NCT05678348 is a Early Phase 1 study of Head and Neck Cancer and Cancer of the Head and Neck that has completed, run by Washington University School of Medicine. The registered enrollment target is 22 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05678348, a Early Phase 1 study of Head and Neck Cancer and Cancer of the Head and Neck, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
NRF2 activation, observed in up to 40% of head and neck squamous cell carcinoma (HNSCC) tumors, plays a critical role in tumor progression, metastasis, and radiation therapy resistance. The investigators have recently discovered that pyrimethamine (PYR) and its analogs have an inhibitory effect on NRF2 activity in vitro and in mouse models via inhibition of dihydrofolate reductase (DHFR). Pyrimethamine is an established drug that has been used for decades for treatment of protozoan infections and malaria. A growing body of research shows that it has potential antitumor activity, however its activity on growing human tumors has not been previously studied. The primary efficacy goal of this study is to evaluate the activity of pyrimethamine on human tumors as demonstrated by inhibition of DHFR and downregulation of NRF2 pathway activity. On-target inhibition of DHFR by pyrimethamine results in the stabilization and increased protein expression of human DHFR. The primary efficacy hypothesis of this study is that treatment with pyrimethamine will result in a 50% increase in DHFR protein within the tumor cells as measured by quantitative western blot analysis. Secondarily, among those tumors classified as NRF2-active on pre-treatment biopsy, the investigators hypothesize there will be a 50% reduction in NRF2 activity as measured by SureQuant targeted proteomic analysis.
Conditions Studied
Interventions
- DRUG Pyrimethamine
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-08-03 |
| Est. Completion | 2025-08-04 |
| Phase | Early Phase 1 |
What the finished NCT05678348 record still lists
NCT05678348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Pyrimethamine is the first listed.
NCT05678348 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05678348 about?
NCT05678348 is a clinical study titled "Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated Locally Advanced Head and Neck Squamous Cell Carcinoma". NRF2 activation, observed in up to 40% of head and neck squamous cell carcinoma (HNSCC) tumors, plays a critical role in tumor progression, metastasis, and radiation therapy resistance. The investigators have recently discovered that pyrimethamine (PYR) and its analogs have an inhibitory effect on N...
What is the current status of trial NCT05678348?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2023-08-03. Estimated completion is 2025-08-04.
What conditions does trial NCT05678348 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Cancer of the Head and Neck.
What interventions are being tested in trial NCT05678348?
The interventions under investigation include: Pyrimethamine (DRUG).
Who is sponsoring clinical trial NCT05678348?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05678348 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05678348's enrollment target sits among peer trials
22 214th of 250 higher than 33 of 250 other Head and Neck Cancer trials
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