Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase 2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after second line or above standard chemotherapy
This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), . Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
416
fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Hutchison Medi Pharma Investigational Site
Hefei, Anhui, China
Hutchison Medi pharma Investigational Site
Beijing, Beijing Municipality, China
overall survival
every two months after end of treatment (EOT) observation period at 30 days after the last medication
Time frame: from randomization until death due to any cause, assessed up to 2 year
progression free survival
Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Objective Response Rate (ORR)
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Disease Control Rate (DCR)
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.
Time frame: from first dose to within 30 days after the last dose
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Hutchison Medi Pharma Investigational Site
Guangzhou, Guangdong, China
Hutchison Medi Pharma investigational site
Shenzhen, Guangdong, China
Hutchison Medi Pharma Investigational Site
Liuchow, Guangxi, China
Hutchison Medi Pharma Investigational Site
Harbin, Heilongjiang, China
Hutchison Medi Pharma Investigational Site
Changsha, Hunan, China
Hutchison Medi Pharma Investigational Site
Changzhou, Jiangsu, China
Hutchison Medi Pharma Investigational Site
Nanjing, Jiangsu, China
Hutchison Medi Pharma Investigational Site
Nantong, Jiangsu, China
...and 5 more locations