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)
Overview
- Phase
- Phase 2
- Intervention
- Anlotinib
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 419
- Locations
- 29
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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；
Arms & Interventions
Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention: Anlotinib
Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention: Placebo
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: From randomization until death (up to 24 months)
Secondary Outcomes
- 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)