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Tests treatment safety and results for Oropharyngeal Dysplasia
Official title A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
ClinicalTrials.gov ID: NCT05865028
What this study is testing
What is APG-157?
APG-157 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for oropharyngeal dysplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients age \> 18 years with biopsy-proven moderate to severe oral dysplasia or carcinoma in situ (CIS) and a visible lesion. Sites include...
- Histologically proven oral cavity or oropharyngeal moderate or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible...
- 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
You likely can't join if
- Pregnant women.
- people who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions.
- people 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...
See the full eligibility 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...
- 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...
- 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.
- Pregnant women.
- people who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions.
- people 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.
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.