Study of Anlotinib in Patients With Gastric Cancer(ALTER0503)
NCT ID: NCT02461407
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
378 participants
INTERVENTIONAL
2015-06-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Anlotinib
Anlotinib p.o. qd
Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo
Placebo p.o. qd
Interventions
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Anlotinib
Anlotinib p.o. qd
Placebo
Placebo p.o. qd
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed advanced gastric adenocarcinoma (including Gastroesophageal junction adenocarcinoma) with measurable lesions outside stomach (RECIST 1.1)
3. Advanced stomach cancer patients who have failed to the second line or higher line chemotherapy treatment
4. \>=18 years old；ECOG PS：0\~1；Estimated life expectancy \>3 months
5. Main organs function is normal;
Exclusion Criteria
2. Patients who have been treated with other VEGFR-TKI small-molecule drugs previously, such as sunitinib, Sorafenib, famitinib, Apatinib, Regorafenib, ect
3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) \]
4. Systemic anti-cancer therapy scheduled 4 weeks prior to assignment or during this study，including cytotoxic therapy，signal transduction inhibitors，immunotherapy(or received mitomycin C within 6 weeks before this study). Extended field radiotherapy(EF-RT) used within 4 weeks prior to assignment or limited field radiotherapy used to assess tumor lesions within 2 weeks prior to assignment;
5. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin;
6. Patients with a clear tendency of gastrointestinal bleeding;
7. Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea etc.)
8. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
9. Patients with any severe and/or unable to control diseases;
10. Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment;
11. Patients with any physical signs of bleeding diathesis or medical history, no matter how serious degree they are; Patients with any CTCAE Grade 3 or higher bleeding events occurred within 4 weeks prior to assignment; Patients with non-healing wounds，ulcers or fractures;
12. Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
13. Patients with drug abuse history and unable to get rid of or Patients with mental disorders
14. Brain metastases patients with symptoms or symptoms controlled \< 2 months;
15. Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now;
18 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital, Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Chongqing Daping Hospital
Chongqing, Chongqing Municipality, China
Union Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Lanzhou General Hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Fourth Hospital of Hebei Medical University Tumor Hospital of Hebei Province
Shijiazhuang, Hebei, China
Harbin medical university affiliated tumor hospita
Harbin, Heilongjiang, China
Henan Province Tumor Hospital
Luoyan, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The Third Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
The General Hospital of Nanhua University
Hengyang, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nantong Cancer Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Shandong Tumor Hospital
Jinan, Shandong, China
Linyi City Tumor Hospita
Linyi, Shandong, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Tangdu Hospital of The fourth Military Medical University
Xian, Shanxi, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Yunnan Province Tumor Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital School of Medical,Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Shen Lin, Doctor
Role: CONTACT
Facility Contacts
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Kangsheng Gu, doctor
Role: primary
Lin Shen, Doctor
Role: primary
Jianming Xu, doctor
Role: primary
Dong Wang, Doctor
Role: primary
Xiaoyan Lin, Doctor
Role: primary
Zengqing Guo, doctor
Role: primary
Baihong Zhang, Doctor
Role: primary
Ruihua Xu, Doctor
Role: primary
Kehe Chen, Doctor
Role: primary
Ruixing Zhang, Doctor
Role: primary
Yanqiao Zhang, Doctor
Role: primary
Xiaobing Chen, Doctor
Role: primary
Yanru Qin, Doctor
Role: primary
Tao Zhang, Doctor
Role: primary
Shiying Yu, Doctor
Role: primary
Meizuo Zhong, Doctor
Role: primary
Peiguo Cao, Doctor
Role: primary
Xianli Yin, Doctor
Role: primary
Wenxiang Dai, Doctor
Role: primary
Changping Wu, Doctor
Role: primary
Jianwei Lu, doctor
Role: primary
Yongqian Shu, doctor
Role: primary
Weidong Yao, doctor
Role: primary
Jianping Xiong, Doctor
Role: primary
Anwen Liu, Doctor
Role: primary
Yiye Wan, doctor
Role: primary
Ying Chen, Doctor
Role: primary
Baoli Qin, doctor
Role: primary
Changzheng Li, Doctor
Role: primary
Jianhua Shi, Doctor
Role: primary
Tianshu Liu, Doctor
Role: primary
Liwei Wang, Doctor
Role: primary
Jin Li, doctor
Role: primary
Jie Min, doctor
Role: primary
Yi Ba, doctor
Role: primary
Diansheng Zhong, Doctor
Role: primary
Jian Dong, Doctor
Role: primary
Hongming Pan, Doctor
Role: primary
Other Identifiers
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ALTN-05-II
Identifier Type: -
Identifier Source: org_study_id