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Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma

NCT03502148 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-21

Study results available
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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

Conditions

  • Oral Squamous Cell Carcinoma

Interventions

DRUG

PRV111 (Cisplatin Transmucosal System)

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Privo Technologies

    lead INDUSTRY

Principal Investigators

  • Manijeh Goldberg, PhD · CEO, Privo Technologies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2019-10-27
Completion
2020-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502148 on ClinicalTrials.gov