NCT02764268已完成不适用
Apatinib Dose Titration: Analyses of Exposure, Safety and Efficacy in Advanced or Metastatic Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Interruptions
研究概览
简要总结
Apatinib dose titration in Advanced or Metastatic Gastric Cancer
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 and ≤ 70 years of age
- •Histological confirmed advanced or metastatic adenocarcinoma of the stomach
- •Have failed for at least 2 lines of chemotherapy
- •Life expectancy of at least 12 weeks
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
- •Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
- •More than 4 weeks for operation or radiotherapy or cytotoxic agents
- •Adequate hepatic, renal, heart, and hematologic functions
排除标准
- •Pregnant or lactating women
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- •Any factors that influence the usage of oral administration
- •Evidence of central nerves system metastasis
- •Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure
- •proteinuria ≥ (+)
- •International Normalized Ratio > 1.5 and activated partial thromboplastin time > 1.5 × Upper limit of normal（ULN）
- •Certain possibility of gastric or intestine hemorrhage
- •Less than 4 weeks from the last clinical trial
- •Prior VEGFR inhibitor treatment
- •Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc
研究组 & 干预措施
Apatinib
Experimental
干预措施: Apatinib (Drug)
结局指标
主要结局
Number of Participants With Dose Interruptions
时间窗: 15 months
次要结局
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE(Common Terminology Criteria for Adverse Events) v4.0(15 months)
- Objective Response Rate(ORR)(15 months)
- Disease Control Rate(DCR)(15 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric CancerAdvanced Gastric CancerNCT03255811DongMa40
Unknown
3 期
Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/CisplatinSmall Cell Lung CancerNCT02875457Third Military Medical University100
已完成
2 期
Efficacy and Safety of Apatinib Combined With S-1 for Patients With Advance Gastric CancerGastric CancerNCT04338438Beijing Friendship Hospital37
Unknown
不适用
The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui ProvinceGastric CancerNCT03333967The First Affiliated Hospital of Anhui Medical University1,000
Unknown
不适用
The Real World Study of Apatinib for Gastric Cancer Treatment in Henan ProvinceGastric CancerNCT03478943Henan Cancer Hospital1,000