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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Placebo; Drug: Anlotinib

• Registration Number: NCT02332499
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2015-01-03
• Study First Posted: 2015-01-06
• Primary Completion: 2016-08-18
• Study Completion: 2019-03-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-19
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From randomization until death (up to 24 months)

Secondary Outcome Measures

Name	Time	Method
Progress free survival (PFS)	each 42 days up to PD or death(up to 24 months)
Disease Control Rate (DCR)	each 42 days up to intolerance the toxicity or PD (up to 24 months)
Objective Response Rate (ORR)	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

Trial Locations

Locations (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, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

The 307th Hospital of Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, 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

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