A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Phase II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Elizabeth J Franzmann
32 participants
May 24, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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.
- Histologically proven oral cavity or oropharyngeal moderate or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible lesion on oral exam.
- Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy
- Willing to provide blood, oral rinse and tissue from diagnostic biopsies
- Leukocytes >=3,000/microliter
- Willing to use adequate contraception, subject or partner has had a vasectomy or partner is using effective birth control or is post-menopausal for the duration of the study.
- Able to take oral medication.
- Able to understand and the willingness to sign a written informed consent document.
Exclusion Criteria10
- Pregnant women.
- Subjects who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions.
- Subjects who have had a fracture of the mandible or maxilla within the previous 8 weeks.
- Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
- History of prior head and neck squamous cell carcinomas (HNSCC) unless curatively treated 1 year or more prior.
- Use of chemotherapy and/or radiation for any malignancy (excluding nonmelanoma skin cancer and cancer confined to organs with removal as only treatment) in the past 2 years.
- Subjects with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.
- History of allergic reactions attributed to compounds of similar chemical composition to Curcumin (turmeric).
- Severe thrombocytopenia increasing the risk of biopsy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05865028