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

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ClinicalTrials.gov Identifier: NCT03502148
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Privo Technologies

Study Description
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Brief Summary:
Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3 or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled to occur during the 3 weeks prior to the standard of care tumor resection.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma Drug: PRV111 (Cisplatin Transmucosal System) Phase 1 Phase 2

Detailed Description:

Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3 or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled to occur during the 3 weeks prior to the standard of care tumor resection. After the surgery, subjects will be followed for 6 months for disease recurrence.

Ten subjects will be enrolled in Stage 1 of the study and will receive permeation enhancer and 3 treatment applications of the cisplatin drug-loaded patch at each treatment visit. Up to 21 additional subjects will enroll in Stage 2 for the purpose of 16 total evaluable subjects at the final dose for the efficacy analysis. In Stage 2, the dose may be escalated, de-escalated or remain the same based on the results in Stage 1. All subjects will be followed for 6 months post surgery for disease recurrence.

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1/2, Open-Label, Single-Arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-Label, Single Arm Study of PRV111
In Stage 1, subjects will receive 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery. Following review of Stage 1 subject data, additional subjects will be enrolled in Stage 2 and will receive 2, 3 or 5 treatment applications dependent on the results of Stage 1 at each of the 4 visits prior to their tumor surgery.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Determination of a safe and efficacious dose of PRV111 [ Time Frame: Subjects will be evaluated for safety and efficacy through study completion which is approximately 7 months. ]
    Based on the incidence of adverse events and tumor response


Secondary Outcome Measures :
  1. Evaluate tumor volume shrinkage [ Time Frame: Assessed within the 21 days prior to surgical excision of the tumor ]
    Assessed by imaging at baseline and at the time of surgical excision

  2. Assess long-term safety [ Time Frame: Assessed 1, 3 and 6 months post surgery ]
    Determine safety during post surgery follow-up visits by review of laboratory values and adverse events graded by CTCAE.

  3. Evaluate systemic, tumor and lymph node (if available) platinum levels following PRV111 administration [ Time Frame: Assessed for 21 days from baseline through surgical excision of the tumor ]
    Assessed using bioanalytical methods

  4. Evaluate device technical success including the residual cisplatin level in the patch after application [ Time Frame: Assessed during the 4 treatment visits in the 21 days prior to surgery ]
    Evaluate patch adhesion during application and residual cisplatin level post administration by bioanalytical methods.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Tumors must be amenable to surgical resection no later than 21 days post Visit 1.
  4. Clinically or radiologically measurable tumor.
  5. ECOG Performance Status of < or =2.
  6. Adequate renal function as demonstrated by renal creatinine clearance.
  7. Adequate organ function as assessed by safety labs.
  8. Agree to use effective contraception for 30 days after the last dose of study drug.
  9. Absence of any serious medical conditions that would impair the subject's ability to participate.
  10. Willing and able to provide written informed consent.
  11. Able to return to the study site for treatment and follow-up visits as defined in the protocol.

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502148


Contacts
Contact: Susan Szambelan 5084043454 susan.szambelan@gmail.com
Contact: Manijeh Goldberg, PhD 9786091465 mgoldberg@privotechnologies.com

Locations
United States, Ohio
University of Cincinnati Cancer Institute Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Lisa Schmid, BSN    513-584-0502    wallslm@ucmail.uc.edu   
Principal Investigator: Alice Tang, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Vlad Sandulache, MD    713-798-7218    vlad.sandulache@BCM.edu   
Ben Taub Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Vlad Sandulache, MD    713-798-7218    vlad.sandulache@bcm.edu   
Harris health System - Smith Clinic Recruiting
Houston, Texas, United States, 77054
Contact: Vlad Sandulache, MD    713-798-7218    vlad.sandulache@bcm.edu   
The University of Texas Health Science Center School of Dentistry Recruiting
Houston, Texas, United States, 77054
Contact: Simon Young, DDS, MD, PhD    713-486-2568    Simon.Young@uth.tmc.edu   
Sponsors and Collaborators
Privo Technologies
Investigators
Study Director: Manijeh Goldberg, PhD CEO, Privo Technologies
More Information
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Responsible Party: Privo Technologies
ClinicalTrials.gov Identifier: NCT03502148     History of Changes
Other Study ID Numbers: CLN-001
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Cisplatin
Antineoplastic Agents