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
Additional locations may be listed on ClinicalTrials.gov for NCT03502148.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationPrivo Technologies
