NCT01874873已完成2 期
Phase 2 Study of Anlotinib in Advanced Medullary Thyroid Carcinoma
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
- 58
- 试验地点
- 10
- 主要终点
- enhanced CT scan
研究概览
简要总结
Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to explore ALTN for the effectiveness of advanced medullary thyroid carcinoma and security.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.late medullary thyroid carcinoma; 2.18-70years, ECOG:0-2,Expected survival period >3 months; 3.Calcitonic≥500pg/ml, thyroid function normal; 4.HB≥100g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT
- •80×109/L ,BIL/Cr in normal range,ALT/AST(aspartate aminotransferase )≤1.5*ULN(for hepatic metastases,ALT/AST(aspartate aminotransferase )≤5*ULN) ;TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF
- •LLN. 5.Username contraceptive during the study and after 6 months; 6.Volunteer.
排除标准
- •1.Received vascular endothelial growth inhibitor type of targeted therapy; 2.Subject was diagnosed with The second cancer; 3.Participated in other clinical trials in four weeks; 4.Received in other radiotherapy or chemotherapy treatment in four weeks; 5.With AE> 1; 6.Has influence of oral drugs; 7.Brain metastases, spinal cord compression, cancerous meningitis, or the brain/soft meningeal disease patient; 8.Any serious or failed to control the disease 9.Artery/venous thrombotic; 10.Coagulant function abnormality; 11.Arteriovenous thrombosis event; 12.History of psychiatric drugs abuse or a mental disorder; 13.Immunodeficiency history; 14.Concomitant diseases.
研究组 & 干预措施
Anlotinib
Experimental
干预措施: Anlotinib (Drug)
结局指标
主要结局
enhanced CT scan
时间窗: each 42 days up to 48 months
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(each 21 days up to up to 48 months)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
A Phase II Study of Anlotinib in STS PatientsCancerNCT01878448Chia Tai Tianqing Pharmaceutical Group Co., Ltd.166
已完成
1 期
A Phase I Study of Anlotinib on Tolerance and PharmacokineticsAdvanced CancerNCT01833923Chia Tai Tianqing Pharmaceutical Group Co., Ltd.35
Unknown
2 期
Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs TherapyRenal Cell CarcinomaNCT02072044Chia Tai Tianqing Pharmaceutical Group Co., Ltd.60
已完成
2 期
Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）Non-small Cell Lung CancerNCT01924195Chia Tai Tianqing Pharmaceutical Group Co., Ltd.117
Unknown
2 期
Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）AnlotinibRCCNCT02072031Chia Tai Tianqing Pharmaceutical Group Co., Ltd.133