NCT02711969已完成1 期
A PhaseⅠStudy of Apatinib Mesylate (YN968D1) 1,000mg in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer Failed to Standard Therapy
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年3月最近更新:
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
- 6
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer
研究概览
简要总结
An open study to evaluate the safety of apatinib mesylate (YN968D1) 1,000mg monotherapy in patients with unresectable locally advanced or metastatic Gastric cancer failed to standard therapy.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older
- •Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
- •Failure or noncompliance of existing standard treatment without alternative treatment
- •Measurable disease measured by proper image examination defined by RECIST 1.1
- •Life expectancy ≥ 3 months
- •Subject must be suitable for oral administration of study medication
- •Subject who can submit a written consent form before participating in the test
- •Adequate bone marrow, renal, and liver function
- •Electrocorticography(ECOG) performance status ≤ 2
- •Ability and willingness to comply with the study protocol for the duration of the study
排除标准
- •Pregnant or lactating women
- •Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to first scheduled dose of YN968D1
- •Hemoptysis within 3 months prior to first scheduled dose of YN968D1
- •Cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of YN968D1
- •Surgery or biopsy within 28 days prior to first scheduled dose of YN968D1
- •Minor surgery within 7 days prior to first scheduled dose of YN968D1
- •Patients who have experience using YN968D1 before
- •Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19
- •Known history of human immunodeficiency virus infection (HIV)
- •Medical history of other cancers (including blood cancer) in the 5 years
- •Radiology therapy to target lesion within 28 days, or diagnosis of other cancer within 14 days prior to first scheduled dose of YN968D1
- •History of bleeding diathesis or bleeding within 14 days prior to enrollment
- •Medical history of clinically significant thrombosis (bleeding or clotting disorder) within the past 3-months
- •History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months
- •History of idiopathic or hereditary angioedema, sickle cell or any hemolytic anemia
- •History of uncontrolled hypertension that in the opinion of the investigator
- •Complete Left bundle branch block (LBBB) or bifascicular (RBBB and left anterior or posterior hemi-block)
- •Clinically significant S-T segment or T wave abnormality
- •Abnormal atrial fibrillation
- •History of ECOG or left ventricular ejection fraction (LVEF) abnormality during last 3 months in the opinion of the investigator
- •Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication
- •Congestive heart failure (New York Heart Association class III-IV)
- •History of other significant cardiovascular disease or vascular disease within the last 6 months
- •History of clinically significant glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
- •Half-life of other investigator drug is not passed over fivefold or 30 days prior to clinical trial
- •Known recreational substance use or psychiatric illness that, in the opinion of the Investigator, may affect compliance with scheduled visits
- •Known hypersensitivity to YN968D1 or components of the formulation
研究组 & 干预措施
Apatinib mesylate
Experimental
干预措施: Apatinib mesylate (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs) of Apatinib mesylate in patients with unresectable locally advanced or metastatic gastric cancer
时间窗: First 28 days of dosing
Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
次要结局
- Incidence of Adverse events (AEs), Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities(From date of registration to time of first progressive disease(PD) or death, an average of 1 year)
- Duration of Response(Stable disease, partial response or Complete response)(From date of registration to time of first progressive disease(PD) or death, an average of 1 year)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
The Clinical Research of Mesylate Apatinib Combined With Docetaxel and S-1 as the First-line Treatment of Metastatic Gastric CancerMetastatic Gastric CancerNCT03154983Zhou Fuxiang48
已完成
2 期
Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT04350190Wei Jiang25
招募中
2 期
Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue SarcomaSoft Tissue SarcomaNCT04012827Sun Yat-sen University108
Unknown
1 期
Apatinib Combined With Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast CancerAdvanced Triple Negative Breast CancerNCT05019690Fujian Cancer Hospital20
已完成
2 期
Apatinib for Esophageal Squamous Cell Cancer After the Failure of Standard TreatmentEsophageal Squamous Cell CarcinomaNCT02976896Yuhong Li43