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Recruiting NCT05865028

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

Phase II Interventional Oropharyngeal Dysplasia Oral Cavity Dysplasia Oral Carcinoma in Situ

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APG-157.
Who it may be relevant to
Registry conditions: Oropharyngeal Dysplasia, Oral Cavity Dysplasia, Oral Carcinoma in Situ. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug APG-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.

Primary outcome measures

  • Pathologic Response Rate [Time frame: Up to 12 weeks]
Secondary outcome measures (3)
  • Clinical Response Rate [Time frame: Up to 12 weeks]
  • Change in Lesion Appearance Before and After Protocol Therapy [Time frame: Baseline, 12 weeks post-intervention, Up to 28 months]
  • Number of Treatment-Related Adverse Events and Serious Adverse Events [Time frame: Up to 16 weeks]

Eligibility 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 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.
  • 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. Exceptions to this Exclusion Criteria can be made if patient status is deemed not clinically significant by the PI.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT05865028 · 20221112 · NCI-2023-04230

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗