Metastatic Colorectal Cancer
Conditions
Keywords
Anlotinib, Metastatic Colorectal Cancer （mCRC）, ALTER0703
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.
Interventions
DRUGAnlotinib
Anlotinib p.o. qd
DRUGPlacebo
Placebo p.o. qd
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From randomization until death (up to 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS) | each 42 days up to PD or death(up to 24 months) |
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Disease Control Rate (DCR) | 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 |
Countries
China
Outcome results
None listed