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

NCT03502148 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: CLN-001FD-R-0063255R44CA192875-05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (2)

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

  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

  Subjects were evaluated for efficacy during the 4 treatment visits in the 21 days prior to surgery

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

  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

  4 treatment visits in the 21 days prior to surgery

Secondary Outcomes (5)

• Tumor Response (Tumor Volume Change From Baseline and Pre-op Visit, Approximately 21 Days Prior to Surgical Excision of the Tumor)

  Assessed within the 21 days prior to surgical excision of the tumor

• Number of Loco-regional Recurrences

  Assessed 1, 3 and 6 months post surgery

• Tumor and Lymph Node (if Available) Platinum Levels

  21 days from baseline through surgical excision of the tumor

• Technical Success - Residual Cisplatin Levels Post-application

  4 treatment visits in the 21 days prior to surgery

• Systemic Platinum Levels (Cmax)

  Cmax is a single value of the highest concentration of platinum in the blood reported from samples taken post-dose across all 4 treatment visits (Baseline [0], 30, 60, and 120 minutes at Visits 1-4)

Study Arms (1)

Open-Label, Single Arm Study of PRV111

EXPERIMENTAL

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.

Drug: PRV111 (Cisplatin Transmucosal System)

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.

Also known as: cisplatin

Open-Label, Single Arm Study of PRV111

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed T1 (\<2 cm) or T2 (\>2 cm but \< or = 4 cm) squamous cell carcinoma (SCC) of the lip or oral cavity (anterior 2/3 of the tongue, floor of mouth, lower and upper gingiva, salivary gland, hard palate, and buccal mucosa).
• Tumor must be easily accessible, with no evidence of infection or active bleeding, encroaching major vessels or clinical evidence of neural invasion. Not previously irradiated.
• Tumors must be amenable to surgical resection no later than 21 days post Visit 1.
• Clinically or radiologically measurable tumor.
• ECOG Performance Status of \< or =2.
• Adequate renal function as demonstrated by renal creatinine clearance.
• Adequate organ function as assessed by safety labs.
• Agree to use effective contraception for 30 days after the last dose of study drug.
• Absence of any serious medical conditions that would impair the subject's ability to participate.
• Willing and able to provide written informed consent.
• Able to return to the study site for treatment and follow-up visits as defined in the protocol.

You may not qualify if:

• Known distal metastasis of the SCC of the oral cavity.
• Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to screening.
• Concurrent documented malignancy, with the exception of localized SCC of the skin.
• Exposure to any investigational agent within 3 months prior to screening.
• Known allergy or hypersensitivity to platinum-containing agents.
• Active, uncontrolled infection requiring systemic therapy.
• Known or suspected pregnancy, planned pregnancy or lactation.

Sponsors & Collaborators

• Privo Technologies: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center School of Dentistry

Houston, Texas, 77054, United States

Location

Related Publications (1)

• Goldberg M, Manzi A, Birdi A, Laporte B, Conway P, Cantin S, Mishra V, Singh A, Pearson AT, Goldberg ER, Goldberger S, Flaum B, Hasina R, London NR, Gallia GL, Bettegowda C, Young S, Sandulache V, Melville J, Shum J, O'Neill SE, Aydin E, Zhavoronkov A, Vidal A, Soto A, Alonso MJ, Rosenberg AJ, Lingen MW, D'Cruz A, Agrawal N, Izumchenko E. A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer. Nat Commun. 2022 Aug 17;13(1):4829. doi: 10.1038/s41467-022-31859-3.

  PMID: 35977936 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Dr. Manijeh Goldberg
• Organization: Privo Technologies

mgoldberg@privotechnologies.com

9785872322

Study Officials

• Manijeh Goldberg, PhD

  CEO, Privo Technologies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1/2, Open-Label, Single-Arm

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: April 18, 2018
• Study Start: June 19, 2018
• Primary Completion: October 27, 2019
• Study Completion: May 6, 2020
• Last Updated: October 21, 2022
• Results First Posted: October 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)