NCT02833155已完成1 期
A Phase I and Pharmacokinetic Study to Evaluate Histone Deacetylase Inhibitor, Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer
Taizhou EOC Pharma Co., Ltd.4 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2016年8月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Adverse events, 12-lead ECG, blood pressure/pulse, temperature, laboratory parameters and physical examination.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerance of entinostat administered orally as a single agent in a weekly dosing schedule. Additionally, this study will characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced breast cancer. And to define the profile of adverse events, including laboratory parameters in these subjects
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study patients should fulfil the following criteria:
- •Provision of informed consent prior to any study specific procedures.
- •Postmenopausal women aged ≤ 65years.
- •Estrogen receptor (ER) and / or progesterone receptor (PR) positive breast cancer confirmed by pathology.
- •Once received a non-steroidal aromatase inhibitor (letrozole / anastrozole) treatment, the disease recurrence or progression of breast cancer currently.
- •Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •And recently (past 2 months), weight loss is no more than 10% of average weight.
- •Patients must have a life expectancy >3 months.
- •Patients must have adequate organ and bone marrow function as defined by the following laboratory results.
- •.absolute neutrophil count ( ANC )≥ 1,500 /mm3
- •. Platelets≥100,000 /mm3
- •. White blood cell count(WBC） ≥ 3,000 /mm3
- •. Hemoglobin ≥ 9 g/dL.
- •. Creatinine ≤ 1.5 times the upper limit of normal (ULN) for the institution or Creatinine clearance ≥ 60 ml/min/1.73m2
- •. Total bilirubin ≤ 1.5 times the upper limit of normal for the institution(ULN)
- •.Aspartate transaminases (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 times the upper limit.
- •Patients must be able to take drugs and don't spit out, no malabsorption problem.
- •Able to comply with study procedures and follow-up examinations.
排除标准
- •Patients have known central nervous system metastasis except patients who have terminated steroid treatment for brain metastasis or spinal cord compression with remain disease stable for at least 1 month.
- •Previous treatment with entinostat or any other histone deacetylase inhibitor (Valproic acid, Chidamide etc).
- •Known allergy to any ingredients of entinostat and other drugs in the same class.
- •Women who are pregnant or breast-feeding (premenopausal). For women of childbearing potential, agreement to use a medically approved contraception measures (such as the intrauterine device (IUD), birth control pills or condoms) and to continue its use for the duration of study treatment and for 3 months after the last dose of study treatment.
- •Had received chemotherapy/radiotherapy or other anticancer therapy during the study or within 4 weeks of start of study treatment. Patients must completely recovered from all adverse events due to previous agents administered before 4 weeks (except alopecia).
- •Major surgery within 28 days of start of study treatment.
- •Patients have serious or uncontrolled systemic disease (such as severe liver dysfunction, severe renal dysfunction, poorly controlled diabetes, poorly controlled acute infections). Unstable or decompensated respiratory or cardiovascular disease, or peripheral vascular disease (including diabetic vascular disease), or organ transplantation.
- •Received potent CYP1A2 or CYP3A4 inducer and/or inhibitor (including but not limited following drug: ketoconazole, rifampicin, atazanavir, Clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice, rifabutin, phenytoin, Carbamazepine and phenobarbital).
- •Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [cervical intraepithelial neoplasia （CIN）/cervical carcinoma in situ] or melanoma in-situ). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
- •Active bleeding or new thrombotic diseases using of anticoagulant drugs, patients with bleeding tendency.
- •Meet with any of the following criteria about cardiac parameters:
- •the corrected QT interval (QTc) >470 msec under resting conditions.
- •myocardial infarction or arterial thrombosis events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease.
- •Resting ECG imply any clinically significant abnormal on rhythm, conduction and morphology, for example, left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec.
- •Any factors (such as, heart failure, hypokalemia, inherited long QT syndrome, acquired long QT syndrome or family history of unexplained sudden death in immediate family members under 40 years old) or known combined drug (such as, sotalol, cisapride, clozapine, amiodarone and erythromycin, etc.) to increase risk of prolongation of QTc interval or arrhythmic event.
- •History of or known human immunodeficiency virus (HIV) infection
- •Known drug or long-term alcoholics.
- •Patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study.
- •Involvement in the planning and conduct of the study.
- •Possible of lower inclusion criteria according to the researchers (such as weak, etc), or the other is not suitable for this study.
研究组 & 干预措施
Entinostat and Exemestane
Experimental
Patients receive entinostat PO on days 1, 8, 15, and 22. Entinostat in combination with exemestane will be repeatedly administered every 28 days in the absence of disease progression or unacceptable toxicity.
Exemestane wil be orally administered once daily for up to six months.
干预措施: Entinostat (Drug)
Entinostat and Exemestane
Experimental
Patients receive entinostat PO on days 1, 8, 15, and 22. Entinostat in combination with exemestane will be repeatedly administered every 28 days in the absence of disease progression or unacceptable toxicity.
Exemestane wil be orally administered once daily for up to six months.
干预措施: Exemestane (Drug)
结局指标
主要结局
Adverse events, 12-lead ECG, blood pressure/pulse, temperature, laboratory parameters and physical examination.
时间窗: Up to 28 days
次要结局
- tmax,time at which maximum plasma concentration was observed(Pre-dose, Days 1,2,3,4,5,7,15 and 22)
- Cmax,maximum plasma concentration(Pre-dose, Days 1,2,3,4,5,7,15 and 22)
- AUC 0-168h area under the plasma concentration-time curve from time zero to 168h(Pre-dose, Days 1,2,3,4,5 and 7)
- lambda z , apparent terminal phase elimination constant (λz)(Pre-dose, Days 1,2,3,4,5,7,15 and 22)
- T1/2, elimination half-life(Pre-dose, Days 1,2,3,4,5,7,15 and 22)
- MRT，mean residence time(Pre-dose, Days 1,2,3,4,5,7,15 and 22)
- AUC 0-inf,area under the plasma concentration-time curve from time zero to infinity(Pre-dose, Days 1,2,3,4,5,7,15 and 22)
研究者
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
2 期
Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell CarcinomaRenal Cell CarcinomaNCT03552380Roberto Pili18
已完成
1 期
Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid TumorsBrain Stem NeoplasmPineal Region NeoplasmRecurrent LymphomaRecurrent Malignant Solid NeoplasmRecurrent Primary Central Nervous System NeoplasmRecurrent Visual Pathway GliomaRefractory LymphomaRefractory Malignant Solid NeoplasmRefractory Primary Central Nervous System NeoplasmRefractory Visual Pathway GliomaNCT02780804National Cancer Institute (NCI)21
已完成
1 期
Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)Mismatch Repair-Proficient Colorectal CancerMelanomaNon-Small Cell Lung CancerNCT02437136Syndax Pharmaceuticals191
已完成
1 期
Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has SpreadExtensive Stage Lung Small Cell CarcinomaMalignant Solid NeoplasmMetastatic Malignant Neoplasm in the BrainNCT04631029National Cancer Institute (NCI)3
已完成
1 期
Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian CancerPeritoneal CancerFallopian Tube CancerEpithelial Ovarian CancerNCT02915523Syndax Pharmaceuticals140