A Single Center, Single-arm, Phase II Study of Anlotinib in Subjects With Advanced Malignancy

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 个研究点分布在 1 个国家目标入组 93 人2013年8月1日

适应症Advanced Malignancy

干预措施Anlotinib

概览

阶段: 2 期
干预措施: Anlotinib
疾病 / 适应症: Advanced Malignancy
发起方: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
入组人数: 93
试验地点: 1
主要终点: Overall response rate (ORR)
状态: 已完成
最后更新: 6年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Anlotinib is a tyrosine kinase inhibitors (TKI) with high effective in inhibiting angiogenesis and tumor cell proliferation by targeting VEGFR, PDGFR, FGFR and c-Kit. Previous phase I trial has shown the potency of anlotinib in treating patients with various cancer types who failed in standard treatment or lack proper treatment regimen. Here, a single center, single-arm, phase II study was conducted to further validate the efficacy and safety of anlotinib in these patients.

注册库

clinicaltrials.gov

开始日期

2013年8月1日

结束日期

2015年8月1日

最后更新

6年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

责任方

Sponsor

入排标准

入选标准

•18\~70 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
•Histopathologically confirmed advanced malignancy, including gynecological-related tumors, breast cancer, digestive tract tumors, melanoma, and gastrointestinal stromal tumors.
•Has no effective treatment choice, or failure/recurrence after conventional treatment.
•If has received chemotherapy, the treatment has been discontinued for at least 30 days.
•The main organs function are normally. 6) Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
•Understood and signed an informed consent form.

排除标准

•1）Has other malignant tumors. 2) Has participated in other anticancer drug clinical trials within 4 weeks. 3) Has multiple factors affecting oral medication. 4) Has brain metastasis, spinal cord compression, cancerous meningitis. 5) Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade
•Has any serious and / or uncontrolled disease. 7) Long-term unhealed wounds or fractures. 8) Has artery/venous thrombosis prior to the first dose within 6 months. 9) Has bleeding tendency or treated with anticoagulants or vitamin K antagonists.
•Has drug abuse history that unable to abstain from or mental disorders. 11)Has history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
•According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

研究组 & 干预措施

Anlotinib

Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

干预措施: Anlotinib