NCT05865028招募中2 期
Phase II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia
Elizabeth J Franzmann1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年5月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pathologic Response Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
APG-157 Therapy
Experimental
Participants will receive APG-157 for up to 12 weeks.
干预措施: APG-157 (Drug)
结局指标
主要结局
Pathologic Response Rate
时间窗: 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.
次要结局
- Clinical Response Rate(Up to 12 weeks)
- Change in Lesion Appearance Before and After Protocol Therapy(Baseline, 12 weeks post-intervention, Up to 28 months)
- Number of Treatment-Related Adverse Events and Serious Adverse Events(Up to 16 weeks)
研究者
Elizabeth J Franzmann
Professor
University of Miami
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac DiseaseCeliac DiseaseNCT02637141Amgen64
已完成
2 期
ANG1005 in Patients With Recurrent High-Grade GliomaBrain Tumor, RecurrentGlioblastomaGliomaNCT01967810Angiochem Inc73
已完成
2 期
GW572016 to Treat Recurrent Malignant Brain TumorsGliosarcomaGliomaGlioblastoma MultiformeBrain TumorGBMGSNCT00107003National Cancer Institute (NCI)9
已完成
2 期
A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid CancerThyroid CancerNCT00121628Amgen184
已完成
2 期
Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic UlcersIschemiaUlcersArterial Occlusive DiseasePeripheral Vascular DiseaseNCT00189540AnGes USA, Inc.27