Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)
ALTER0703
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)
1 other identifier
interventional
419
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2014
Typical duration for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 31, 2014
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 21, 2019
May 1, 2019
1.7 years
December 31, 2014
May 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
From randomization until death (up to 24 months)
Secondary Outcomes (4)
Progress free survival (PFS)
each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Until 30 day safety follow-up visit
Study Arms (2)
Anlotinib
ACTIVE COMPARATORAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo
PLACEBO COMPARATORPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Interventions
Eligibility Criteria
You may qualify if:
- Signed and dated informed consent；
- Histological or cytological documentation of adenocarcinoma of the colon or rectum；
- Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
- Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
- ECOG PS:0-1,Life expectancy of more than 3 months；
- main organs function is normal；
- main organs function is normal；
You may not qualify if:
- Prior treatment with Anlotinib；
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
- Known brain metastases；
- patients with severe and failed to controlled diseases；
- patients occurred venous thromboembolic events within 6 months；
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
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, 100021, 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, 150000, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yihebali Chi, doctor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Jianqiang Cai, doctor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Jinwan Wang, doctor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2014
First Posted
January 6, 2015
Study Start
December 1, 2014
Primary Completion
August 18, 2016
Study Completion
March 1, 2019
Last Updated
May 21, 2019
Record last verified: 2019-05