Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Subjects received 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery.

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.

PRV111 (Cisplatin Transmucosal System)

Manijeh Goldberg, PhD

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

Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer and 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. After the surgery, subjects were followed for 6 months for disease recurrence.

Ten subjects were enrolled in the study. Up to 21 additional subjects could have been enrolled in Stage 2, if safety and efficacy endpoints were not met. The dose was not changed. All subjects were followed for 6 months post-surgery for disease recurrence.

During and at the conclusion of the treatment period, subjects were monitored for local and systemic safety, tumor response due to the treatment, and systemic drug exposure.

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

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

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

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 reported dose-limiting toxicities during the PRV111 treatment period

Assessed by clinical measurement at baseline and at the pre-op visit

Number of loco-regional recurrences at follow-up

Levels of platinum content in tumor tissue and/or lymph tissue, using a validated bioanalytical ICP-MS method. Resected tissues were digested via microwave and used to evaluate the amount of cisplatin delivered by PRV111 (Correlated to the amount of platinum detected).

Platinum content in each residual PRV111, using a validated bioanalytical ICP-MS method and the results for all applications were averaged.

Levels of platinum content in blood, using a validated bioanalytical ICP-MS method. Blood drawn was digested via microwave and used to evaluate the amount of systemic cisplatin exposure from PRV111 (Correlated to the amount of platinum detected). A single value for Cmax was calculated by averaging values for all subjects.

National Cancer Institute (NCI)

Privo Technologies

Subjects received at least 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery.

Neoadjuvant PRV111 (Safety Population)

Subjects received 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits (within 3 weeks prior to their tumor surgery). Each treatment included one application of permeation enhancer prior to PRV111 administration.

Open-Label, Single Arm Study of PRV111

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All subjects included in the baseline analysis were included in the safety population. Eight subjects were evaluable for the efficacy population.

Dr. Manijeh Goldberg

Subjects who completed at least 3/4 planned PRV111 treatment visits.

Neoadjuvant PRV111 (Efficacy Population)

The efficacy population consists of all subjects who completed at least 3 PRV111 treatment visits and met all inclusion/exclusion criteria. The outcome measure is expressed as the count of participants who displayed a tumor response (At least 30% tumor volume reduction based on clinical measurements).

Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses

Subjects who received at least a single treatment application of PRV111.

Patients treated with at least 1 PRV111 were included

Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities

Subjects who received at least 3 PRV111 treatments and met all inclusion/exclusion criteria.

Spots Global Cancer Trial Database for prv111 (cisplatin transmucosal system)