Phase 2
N=10
Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma
Oral Squamous Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03502148 ↗Enrolled (actual)
10
Serious AEs
30.0%
Results posted
Oct 2022
Primary outcome: Primary: Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PRV111 (Cisplatin Transmucosal System) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Privo Technologies
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses |
7 | — |
| PRIMARY Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities |
— | — |
| SECONDARY Tumor Response (Tumor Volume Change From Baseline and Pre-op Visit, Approximately 21 Days Prior to Surgical Excision of the Tumor) |
69 | — |
| SECONDARY Number of Loco-regional Recurrences |
— | — |
| SECONDARY Tumor and Lymph Node (if Available) Platinum Levels |
337; 110 | — |
| SECONDARY Technical Success - Residual Cisplatin Levels Post-application |
91.7 | — |
| SECONDARY Systemic Platinum Levels (Cmax) |
0.24 | — |
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
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed T1 ( 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03502148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.