CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
PRV111 (Cisplatin Transmucosal System)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03502148
NCT03502148Phase 2Completed
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Phase 1/2, Open-Label, Single-Arm Safety and Efficacy Dose-Finding, Systemic Exposure, and Device Technical Effects of PRV111 (Cisplatin Transmucosal System) in Subjects With Oral Squamous Cell Carcinoma

Privo Technologies·interventional·Posted Apr 18, 2018·Updated Oct 21, 2022

In Brief

A Phase 2 clinical trial evaluating PRV111 (Cisplatin Transmucosal System) for Oral Squamous Cell Carcinoma. Completed, enrolled 10 participants across 5 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Squamous Cell Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 18, 2018
Enrollment StartJun 19, 2018
Primary CompletionOct 27, 2019
Study CompletionMay 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.2 years ago

Interventions

PRV111 (Cisplatin Transmucosal System)drug

Each treatment visit will include one application of a permeation enhancer and then 2, 3 or 5 PRV111 (Cisplatin Transmucosal System) applications depending on the Stage subject is enrolled in.