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

Metastatic Colorectal Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332499
• Other study ID #: ALTN-07-IIB
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2014
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: March 1, 2019
• Est. primary completion date: August 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd
• Placebo
Placebo p.o. qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The 307th Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	The 1st Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Jilin Cancer Hospital	Changchun	Jilin
China	The Second xiangya Hospital of Central South University	Changsha	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
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	Harbin medical university affiliated tumor hospital	Haerbin	Heilongjiang
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital, Anhui Medical University	Hefei	Anhui
China	Qilu Hospital,Shandong University	Jinan	Shandong
China	Gansu Province Tumor Hospital	Lanzhou	Gansu
China	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Guangxi medical university affiliated tumor hospital	Nanning	Guangxi
China	Nantong Cancer Hospital	Nantong	Jiangsu
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	Liaoning Province Tumor Hospital	Shenyang	Liaoning
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin
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

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		From randomization until death (up to 24 months)
Secondary	Progress free survival (PFS)		each 42 days up to PD or death(up to 24 months)
Secondary	Objective Response Rate (ORR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Disease Control Rate (DCR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Until 30 day safety follow-up visit

External Links

•   Cancer
•   Colorectal Cancer
•   U.S. FDA Resources