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NCT03754933 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer
A Phase 1 study, sponsored by GeoVax.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03754933: Completed Phase 1 study, sponsored by GeoVax.
NCT03754933 is a Phase 1 study that has completed, run by GeoVax. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03754933, a Phase 1 study, has completed, sponsored by GeoVax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Primary Objective: The primary objective of the study is to evaluate the safety of repeat administration of a dose level of Ad/PNP plus fludarabine phosphate (F-araAMP) which demonstrated anti-tumor activity in patients with advanced head and neck cancer in a completed phase I study. Secondary Objective: The secondary objective is to evaluate the antitumor activity of repeat administration of Ad/PNP plus F-araAMP. FDA Office of Orphan Drugs Division is a source of funding for the overall project.
Primary Outcome
Safety measures evaluated by medical history, physical examination, vital signs, inspection of tumor site, performance status, EKG, chest X-ray (CXR), blood chemistry, hematology, CD4/CD8 T-cell counts, urinalysis, PT/PTT, blood sample for adenovirus, urine for adenovirus, F-Ade plasma level, blood sample for antibody against adenovirus, and monitoring adverse events.
Interventions
- DRUG Fludarabine Phosphate
- BIOLOGICAL Ad/PNP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-02-11 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 1 |
What the finished NCT03754933 record still lists
NCT03754933 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Fludarabine Phosphate is the first listed.
NCT03754933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03754933 about?
NCT03754933 is a clinical study titled "Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer". Primary Objective: The primary objective of the study is to evaluate the safety of repeat administration of a dose level of Ad/PNP plus fludarabine phosphate (F-araAMP) which demonstrated anti-tumor activity in patients with advanced head and neck cancer in a completed phase I study. Secondary Obje...
What is the current status of trial NCT03754933?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-02-11. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT03754933?
The interventions under investigation include: Fludarabine Phosphate (DRUG), Ad/PNP (BIOLOGICAL).
Who is sponsoring clinical trial NCT03754933?
This trial is sponsored by GeoVax, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03754933's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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