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NCT03502148 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma
A Phase 1 study, sponsored by Privo Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03502148: Completed Phase 1 study, sponsored by Privo Technologies.
NCT03502148 is a Phase 1 study that has completed, run by Privo Technologies. 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
NCT03502148, a Phase 1 study, has completed, sponsored by Privo Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. Funding Source: FDA OOPD
Primary Outcome
The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2. This measures presents the number of tumor responses during the PRV111 treatment period
Interventions
- DRUG PRV111 (Cisplatin Transmucosal System)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2020-05-06 |
| Phase | Phase 1 |
What the finished NCT03502148 record still lists
NCT03502148 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 1 intervention - of which PRV111 (Cisplatin Transmucosal System) is the first listed.
NCT03502148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03502148 about?
NCT03502148 is a clinical study titled "Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma". Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to ...
What is the current status of trial NCT03502148?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-06-19. Estimated completion is 2020-05-06.
What interventions are being tested in trial NCT03502148?
The interventions under investigation include: PRV111 (Cisplatin Transmucosal System) (DRUG).
Who is sponsoring clinical trial NCT03502148?
This trial is sponsored by Privo Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03502148'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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