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APG-157 for Oral Dysplasia
Phase 2
Recruiting
Led By Elizabeth J Franzmann, MD
Research Sponsored by Elizabeth J Franzmann
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks post-intervention, up to 28 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a new drug can reduce tumor size in people with a certain disease. It also looks at side effects.
Who is the study for?
Adults over 18 with moderate to severe oral dysplasia or carcinoma in situ, visible lesions, and normal organ function can join. They must be able to consent, provide samples, and use contraception if needed. Excluded are those with recent fractures/surgery in the mouth area, certain allergies, liver disease, severe thrombocytopenia, pregnancy, recent cancer treatments (except some skin cancers), uncontrolled illnesses or other significant oral diseases.
What is being tested?
The trial is testing APG-157's ability to shrink tumors in patients with oral dysplasia. It also examines its effects on tumor markers and substances found in mouth rinses of affected individuals.
What are the potential side effects?
While specific side effects for APG-157 aren't listed here, common ones for new drugs may include nausea, allergic reactions like rashes or swelling at the drug application site; fatigue; headaches; digestive issues; and changes in blood tests that monitor liver health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks post-intervention, up to 28 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks post-intervention, up to 28 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic Response Rate
Secondary study objectives
Change in Lesion Appearance Before and After Protocol Therapy
Clinical Response Rate
Number of Treatment-Related Adverse Events and Serious Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: APG-157 TherapyExperimental Treatment1 Intervention
Participants will receive APG-157 for up to 12 weeks.
Find a Location
Who is running the clinical trial?
Aveta Biomics, Inc.Industry Sponsor
3 Previous Clinical Trials
54 Total Patients Enrolled
Elizabeth J FranzmannLead Sponsor
Elizabeth J Franzmann, MDPrincipal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a jaw fracture in the last 8 weeks.I have not had recent oral surgery, except for biopsies or tooth extractions, in the last 8 weeks.I had head or neck cancer but was treated for it over a year ago.I haven't had chemotherapy or radiation for cancer (except skin cancer or cancers treated by surgery alone) in the last 2 years.I am over 18 with a serious oral condition confirmed by biopsy.My doctor considers my mouth or throat condition significant.I have a very low platelet count that increases my risk for biopsy.I have a confirmed severe gum or throat condition with a visible sore.I can take pills by mouth.I have liver disease, hepatitis, cirrhosis, or portal hypertension.I do not have any severe illnesses or social situations that would prevent me from following the trial requirements.
Research Study Groups:
This trial has the following groups:- Group 1: APG-157 Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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