Phase II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Elizabeth J Franzmann
Summary
The purpose of this study is to assess whether APG-157 can reduce the tumor size in participants with the study disease. Another purpose is to find out about the effects of APG-157 on certain tumor markers and oral rinses in participants with the study disease.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult patients age \> 18 years with biopsy-proven moderate to severe oral dysplasia or carcinoma in situ (CIS) and a visible lesion. Sites include all oral cavity as well as oropharyngeal dysplasia that is accessible in the outpatient clinic. 2. Histologically proven oral cavity or oropharyngeal moderate or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible lesion on oral exam. 3. Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy 4. Willing to provide blood, oral rinse and tissue from diagnostic biopsies 5. Leukocyt…
Interventions
- DrugAPG-157
Participants will take 200mg (2 x 100mg pastilles) of APG-157 therapy orally (PO) three times daily during each 4-week cycle for up to three cycles. Cycle three is optional.
Location
- University of MiamiMiami, Florida