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NCT05865028 | Recruiting | Oropharyngeal Dysplasia

A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Sponsor:

Elizabeth J Franzmann

Information provided by (Responsible Party):

Elizabeth J Franzmann

Brief 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.

Condition or disease

Oropharyngeal Dysplasia

Oral Cavity Dysplasia

Oral Carcinoma in Situ

Intervention/treatment

APG-157

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 32 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Phase II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Actual Study Start Date : May 24, 2023
Estimated Primary Completion Date : May 24, 2027
Estimated Study Completion Date : May 24, 2028
Arm Intervention/treatment

Experimental: APG-157 Therapy

Participants will receive APG-157 for up to 12 weeks.

Drug: APG-157
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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 (IUL) of normal (UNL), 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).
  • 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 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).
  • Active or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension.
  • 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, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

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A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

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Locations

Recruiting

United States, Florida

University of Miami

Miami, florida, United States, 33136