NCT01531777已完成2 期
A Random, Open, Dose Finding and Pharmacokinetics/Pharmacodynamics(PK/PD) Phase II Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer
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
- 40
- 试验地点
- 1
- 主要终点
- ORR (Objective Response Rate)
研究概览
简要总结
RATIONALE:
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable.
PURPOSE:
- Studying how well Apatinib works in treating patients.
- Finding the efficacy and safety of 500 mg or 750mg Apatinib.
- Pharmacokinetics/Pharmacodynamics(PK/PD).
- Exploring new outcome measures of antiangiogenic drugs.
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
- None
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 colorectal Cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
- •Have failed for ≥ 2 lines of chemotherapy
- •Life expectancy of more than 3 months
- •ECOG performance scale ≤ 1
- •Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks for operation, radiotherapy or cytotoxic agents
- •Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 10E+9/L, neutrophil > 1.5 × 10E+9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.25 ULN, and serum transaminase ≤ 2.5× ULN)
- •Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
- •Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Pregnant or lactating women
- •Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
- •Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Any factors that influence the usage of oral administration Evidence of CNS metastasis
- •URT: urine protein ≥ (++)and > 1.0 g of 24 h
- •PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
- •Abuse of drugs
- •Certain possibility of gastric or intestine hemorrhage
- •Less than 4 weeks from the last clinical trial
- •Viral hepatitis type B or type C
- •Prior VEGFR inhibitor treatment
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
研究组 & 干预措施
Apatinib 500mg
Experimental
500mg,p.o.,qd
干预措施: apatinib (Drug)
Apatinib 750mg
Experimental
750mg,p.o.,qd
干预措施: apatinib (Drug)
结局指标
主要结局
ORR (Objective Response Rate)
时间窗: 12 weeks
次要结局
- DCR (Disease Control Rate)(12 weeks after treatment)
- PFS(3 years)
- OS (Overall Survival)(3 years)
- QoL (Quality of Life)(3 years)
研究者
研究点 (1)
Loading locations...
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