NCT02597712已完成2 期
Randomized, Placebo-controlled Trial of YF476, a Gastrin Receptor Antagonist, in Barrett's Esophagus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in Ki67 Biomarker Expression
研究概览
简要总结
A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and effective treatment in patients with Barrett's esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged >18 years, with histologically confirmed diagnosis of Barrett's esophagus (BE) without dysplasia. A prior endoscopy with biopsies read as indefinite for dysplasia is permitted if biopsies from the most recent endoscopy prior to study entry demonstrated BE without dysplasia.
- •Minimum of 1 cm circumferential Barrett's mucosa on endoscopy or at least 2 cm maximal contiguous extent of Barrett's mucosa, as measured from the top of the gastric folds to the squamocolumnar junction (Prague criteria C>1, any M or any C, M>2).
- •Proton pump inhibitor use at least once daily, for at least 12 months prior to enrolment, and stable dose of PPI for the 3 months before enrolment. Any PPI, dose, and frequency allowable.
- •ECOG performance status <2 and Karnofsky >60%
- •Normal organ and marrow function, defined as white blood cells >3 x 10e9, absolute neutrophil count >1.5 x 10e9, platelets >100 x 10e9, creatinine <1.5 mg/dL, total bilirubin <1.5 mg/dL, AST <100 U/L, ALT <100 U/L.
- •Use of adequate contraception during the study, as follows;
- •Post-menopausal women must have had their last menstrual period at least 1 year ago.
- •Pre-menopausal women, who are sexually-active, must have had a hysterectomy or bilateral oophorectomy; or must use an intrauterine device (IUD), or spermicide with a diaphragm, cap or condom. Streroid contraceptives such as 'the pill' are not allowed unless in combination with one of the aforementioned barrier contraceptive methods.
- •Men must use a condom and spermicide.
- •Willingness to comply with all treatment and follow-up procedures.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Up to date with all age-appropriate cancer screening tests, as per American Cancer Society guidelines, (Columbia University only), and no cancer screening tests planned for the next 21 weeks.
排除标准
- •Histologically confirmed BE with high-grade dysplasia.
- •Histologically confirmed diagnosis of invasive carcinoma of the esophagus.
- •Histologically confirmed BE with low-grade dysplasia that has been diagnosed by at least 2 expert gastrointestinal pathologists.
- •Prior endoscopic therapy for BE.
- •Any history of esophageal or gastric surgery.
- •History of atrophic gastritis, pernicious anemia, or Zollinger-Ellison syndrome.
- •Participation in a trial of an IMP within the previous 28 days.
- •Prolonged QTc interval >450 msec.
- •History of allergic reactions attributed to compounds of similar chemical composition of YF
- •History of baseline findings of:
- •diabetes mellitus requiring insulin therapy
- •pancreatitis (baseline amylase and/or lipase >2.0 x ULN)
- •hepatitis B, hepatitis C or HIV
- •malabsorption syndrome or inability to swallow or retain oral medicine
- •major surgery <28 days prior to enrolment
- •ECOG performance status >2
- •another cancer within 3 years except for basal carcinoma of the skin or cervical carcinoma in-situ
- •also, any clinically significant and uncontrolled major morbidity including but not limited to: serious cardiac disease (unstable angina, s/p myocardial infarction <1 month); respiratory disease (advanced COPD or pulmonary fibrosis); uncontrolled hypertension; active systemic infection; or psychiatric illness/social situations that would limit compliance with study requirements.
- •Certain medicines and herbal remedies taken during the 7 days before the start of the study drug.
- •A history of cancer >3 years from the time of enrolment, and the patient is not up to date with surveillance for that cancer (based on the American Cancer Society guidelines, Columbia University only), has evidence of cancer at the time of enrolment, or has surveillance tests planned within 21 weeks after enrolment.
研究组 & 干预措施
YF476 Placebo
Placebo Comparator
Patients will take matching placebo once daily for 12 weeks
干预措施: YF476 placebo (Drug)
Treatment
Experimental
Patients will take 25 mg YF476 once daily for 12 weeks
干预措施: YF476 (Drug)
结局指标
主要结局
Change in Ki67 Biomarker Expression
时间窗: Baseline and Week 12
Esophagogastroduodenoscopy (EGD) was performed to enable taking biopsies for assessment of Ki67 expression, a marker of cellular proliferation. Ki67 expression was assessed by immunohistochemistry and calculating the number of Ki67 positive cells per mm\^2 of Barrett's epithelium.
次要结局
- Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC)(Week 12)
- Abundance of Biomarkers of Gastric Acid Suppression(Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment))
- Abundance of Biomarkers of ECL Cell Hyperplasia(Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Trial of a Gastrin Receptor Antagonist in Barrett's EsophagusBarrett's EsophagusNCT01298999Columbia University27
已完成
2 期
Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X SyndromeFragile X SyndromeNCT01357239Novartis Pharmaceuticals139
已完成
2 期
Safety and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeFragile X SyndromeNCT01253629Novartis Pharmaceuticals175
终止
2 期
Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic PainDiabetic Peripheral Neuropathic PainNCT04707157Eli Lilly and Company68
已完成
2 期
Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back PainChronic Low-back PainNCT04874636Eli Lilly and Company153