- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05865028
A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
June 6, 2023 updated by: Elizabeth J Franzmann
Phase II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elizabeth J Franzmann, MD
- Phone Number: 305-243-5955
- Email: efranzman@med.miami.edu
Study Locations
-
-
Florida
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Elizabeth J Franzmann, MD
- Phone Number: 305-243-5955
- Email: efranzman@med.miami.edu
-
Principal Investigator:
- Elizabeth J Franzmann, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APG-157 Therapy
Participants will receive APG-157 for up to 12 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Response Rate
Time Frame: Up to 12 weeks
|
The pathologic response rate among participants receiving study treatment will be assessed.
The pathologic response rate is defined as the percentage of participants with mild or no dysplasia after receiving study therapy.
Response will be assessed on the basis of clinical, radiologic, molecular and pathologic criteria consistent with Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, per physician discretion.
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response Rate
Time Frame: Up to 12 weeks
|
The clinical response rate among participants receiving study treatment will be assessed.
The clinical response rate is defined as the percentage of participants with complete response (CR) and/or partial response (PR) after receiving study therapy.
Response will be assessed on the basis of clinical, radiologic, molecular and pathologic criteria consistent with Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria.
|
Up to 12 weeks
|
Change in Lesion Appearance Before and After Protocol Therapy
Time Frame: Baseline, 12 weeks post-intervention, Up to 28 months
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Change in lesion appearance will be assessed using criteria consistent with Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, found at time of oral exam per physician discretion.
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Baseline, 12 weeks post-intervention, Up to 28 months
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Number of Treatment-Related Adverse Events and Serious Adverse Events
Time Frame: Up to 16 weeks
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The number of treatment-related adverse events (AEs) and serious adverse events (SAEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.
|
Up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth J Franzmann, MD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2023
Primary Completion (Estimated)
May 24, 2027
Study Completion (Estimated)
May 24, 2028
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
May 9, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20221112
- NCI-2023-04230 (Registry Identifier: NCI Clinical Trials Reporting Program (NCI CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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