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 : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oral Squamous Cell Carcinoma||Drug: PRV111 (Cisplatin Transmucosal System)||Phase 1 Phase 2|
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 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)|
|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|
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.
- 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
- 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
- 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.
- 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
- 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.
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
|Contact: Ruthanna Costelloemail@example.com|
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|Louisville, Kentucky, United States, 40207|
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|University of Cincinnati Cancer Institute||Recruiting|
|Cincinnati, Ohio, United States, 45267|
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|Ben Taub Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Simon Young, MD 713-486-2568 Simon.Young@uth.tmc.edu|
|Memorial Hermann Hospital||Recruiting|
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|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|
|Study Director:||Manijeh Goldberg, PhD||CEO, Privo Technologies|