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Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703) (ALTER0703)

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Anlotinib, Metastatic Colorectal Cancer （mCRC）, ALTER0703

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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；

Sites / Locations

  • The 1st Affiliated Hospital of Bengbu Medical College
  • The Second Affiliated Hospital, Anhui Medical University
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Peking Union Medical College Hospital
  • The 307th Hospital of Chinese People's Liberation Army
  • Chongqing Cancer Hospital
  • The Second Affiliated Hospital of Chongqing Medical University
  • Fujian Cancer Hospital
  • Gansu Province Tumor Hospital
  • The First Affiliated Hospital of Sun Yat-sen university
  • The Sixth Affiliated Hospital of Sun Yat-sen university
  • Guangxi medical university affiliated tumor hospital
  • Harbin medical university affiliated tumor hospital
  • The Second xiangya Hospital of Central South University
  • The First People's Hospital of Lianyungang
  • Jiangsu Cancer Hospital
  • Jiangsu Province Hospital
  • Nantong Cancer Hospital
  • Jiangxi Cancer Hospital
  • The First Affiliated Hospital of Nanchang University
  • Jilin Cancer Hospital
  • Liaoning Province Tumor Hospital
  • Qilu Hospital，Shandong University
  • Cancer Hospital of Fudan University
  • Shanxi Cancer Hospital
  • Tangdu Hospital of The fourth Military Medical University
  • The First Affiliated Hospital of Xian Jiaotong University
  • Tianjin Medical University Cancer Hospital
  • The First Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anlotinib

Placebo

Arm Description

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Secondary Outcome Measures

Progress free survival (PFS)
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

First Posted
December 31, 2014
Last Updated
May 19, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02332499
Brief Title
Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)
Acronym
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 18, 2016 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Anlotinib, Metastatic Colorectal Cancer （mCRC）, ALTER0703

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Active Comparator
Arm Description
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Other Intervention Name(s)
AL3818
Intervention Description
Anlotinib p.o. qd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo p.o. qd
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
From randomization until death (up to 24 months)
Secondary Outcome Measure Information:
Title
Progress free survival (PFS)
Time Frame
each 42 days up to PD or death(up to 24 months)
Title
Objective Response Rate (ORR)
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Title
Disease Control Rate (DCR)
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Until 30 day safety follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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； Exclusion Criteria: 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；
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yihebali Chi, doctor
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianqiang Cai, doctor
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinwan Wang, doctor
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
The Second Affiliated Hospital, Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The 307th Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Gansu Province Tumor Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen university
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen university
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangxi medical university affiliated tumor hospital
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Harbin medical university affiliated tumor hospital
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
The Second xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nantong Cancer Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Liaoning Province Tumor Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Qilu Hospital，Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Cancer Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanxi Cancer Hospital
City
Xian
State/Province
Shanxi
Country
China
Facility Name
Tangdu Hospital of The fourth Military Medical University
City
Xian
State/Province
Shanxi
Country
China
Facility Name
The First Affiliated Hospital of Xian Jiaotong University
City
Xian
State/Province
Shanxi
Country
China
Facility Name
Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/cancer.html
Description
Cancer
URL
http://www.nlm.nih.gov/medlineplus/colorectalcancer.html
Description
Colorectal Cancer
URL
https://clinicaltrials.gov/ct2/info/fdalinks
Description
U.S. FDA Resources

Learn more about this trial

Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)

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