Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)
NCT ID: NCT02332499
Last Updated: 2019-05-21
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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COMPLETED
PHASE2/PHASE3
419 participants
INTERVENTIONAL
2014-12-31
2019-03-01
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological or cytological documentation of adenocarcinoma of the colon or rectum；
3. Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
4. Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
5. ECOG PS:0-1,Life expectancy of more than 3 months；
6. main organs function is normal；
7. main organs function is normal；
Exclusion Criteria
2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
3. Known brain metastases；
4. patients with severe and failed to controlled diseases；
5. patients occurred venous thromboembolic events within 6 months；
18 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yihebali Chi, doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jianqiang Cai, doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jinwan Wang, doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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The 1st Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Second Affiliated Hospital, Anhui Medical University
Hefei, Anhui, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Gansu Province Tumor Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Sun Yat-sen university
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen university
Guangzhou, Guangdong, China
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, China
Harbin medical university affiliated tumor hospital
Haerbin, Heilongjiang, China
The Second xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nantong Cancer Hospital
Nantong, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Qilu Hospital，Shandong University
Jinan, Shandong, China
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Xian, Shanxi, China
Tangdu Hospital of The fourth Military Medical University
Xian, Shanxi, China
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Related Links
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Colorectal Cancer
U.S. FDA Resources
Other Identifiers
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ALTN-07-IIB
Identifier Type: -
Identifier Source: org_study_id
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