A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia (NCT05865028) | Clinical Trial Compass
RecruitingPhase 2
A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
United States32 participantsStarted 2023-05-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Absolute neutrophil count \>= 1,000/microliter, Platelets \>= 100,000/microliter, Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN), aspartate aminotransferase (AST), serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) and serum glutamic pyruvic transaminase (SGPT) =\< 1.5 x institutional upper limit of normal (ULN). Exceptions to this Inclusion Criteria can be made if labs are deemed not clinically significant by the principal investigator (PI).
✓. 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.
Exclusion criteria
✕. 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).