Clinical trial NCT02332499: Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)
Official title: Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: Anlotinib
Metastatic Colorectal Cancer （mCRC）
ALTER0703
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-06
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Detailed description: Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Eligibility criteria: Inclusion Criteria:

1. Signed and dated informed consent；
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:

1. Prior treatment with Anlotinib；
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；

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until death (up to 24 months)
Secondary outcomes:
measure: Progress free survival (PFS)
timeFrame: each 42 days up to PD or death(up to 24 months)
measure: Objective Response Rate (ORR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
measure: Disease Control Rate (DCR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Until 30 day safety follow-up visit
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The 1st Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The Second Affiliated Hospital, Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: The 307th Hospital of Chinese People's Liberation Army
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu Province Tumor Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen university
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen university
state: Guangdong
city: Nanning
country: China
facility: Guangxi medical university affiliated tumor hospital
state: Guangxi
city: Haerbin
country: China
facility: Harbin medical university affiliated tumor hospital
state: Heilongjiang
city: Changsha
country: China
facility: The Second xiangya Hospital of Central South University
state: Hunan
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Cancer Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Province Tumor Hospital
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital，Shandong University
state: Shandong
city: Shanghai
country: China
facility: Cancer Hospital of Fudan University
state: Shanghai
city: Xian
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Xian
country: China
facility: Tangdu Hospital of The fourth Military Medical University
state: Shanxi
city: Xian
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yihebali Chi, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jianqiang Cai, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jinwan Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References: