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

May 19, 2019 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • The 1st Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China
        • The second affiliated hospital, anhui medical university
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Beijing, Beijing, China
        • The 307th hospital of chinese People's liberation army
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Cancer Hospital
      • Chongqing, Chongqing, China
        • The Second Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Cancer Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • Gansu Province Tumor Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • The Sixth Affiliated Hospital of Sun Yat-Sen University
    • Guangxi
      • Nanning, Guangxi, China
        • Guangxi Medical University Affiliated Tumor Hospital
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150000
        • Harbin medical university affiliated tumor hospital
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital Of Central South University
    • Jiangsu
      • Lianyungang, Jiangsu, China
        • The first people's hospital of Lianyungang
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • Jiangsu Cancer Hospital
      • Nantong, Jiangsu, China
        • Nantong Cancer Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Cancer Hospital
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China
        • Jilin Cancer Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Province Tumor Hospital
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital，Shandong University
    • Shanghai
      • Shanghai, Shanghai, China
        • Cancer Hospital of Fudan University
    • Shanxi
      • Xian, Shanxi, China
        • The First Affiliated Hospital of Xiân Jiaotong University
      • Xian, Shanxi, China
        • Shanxi Cancer Hospital
      • Xian, Shanxi, China
        • Tangdu hospital of the Fourth Military Medical University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Placebo
Placebo p.o. qd
Active Comparator: Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Anlotinib
Anlotinib p.o. qd
Other Names:
  • AL3818

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death (up to 24 months)
From randomization until death (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Progress free survival (PFS)
Time Frame: each 42 days up to PD or death(up to 24 months)
each 42 days up to PD or death(up to 24 months)
Objective Response Rate (ORR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
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
Time Frame: Until 30 day safety follow-up visit
Until 30 day safety follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 18, 2016

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 3, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 19, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-07-IIB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on Anlotinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe