Spots Global Cancer Trial Database for A Study of Aflibercept Versus Placebo With FOLFIRI in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin Chemotherapy
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Trial Identification
Brief Title: A Study of Aflibercept Versus Placebo With FOLFIRI in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin Chemotherapy
Official Title: A Multinational, Randomized, Double-Blind Study of Aflibercept Versus Placebo With Irinotecan/ 5-FU Combination (FOLFIRI) in Patients With Metastatic Colorectal Cancer (MCRC) After Failure of an Oxaliplatin Based Regimen
Study ID: NCT01661270
Conditions
Study Description
Brief Summary: Primary Objective: To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo in participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment for metastatic disease. Secondary Objectives: To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers.
Detailed Description: Screening occurred from signed informed consent to randomization (up to 21 days). A treatment cycle was defined as a 2 week-period. All participants were followed during the study treatment and follow-up period until death or study cut off date, which ever comes first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 156003, Beijing, , China
Investigational Site Number 156001, Beijing, , China
Investigational Site Number 156002, Beijing, , China
Investigational Site Number 156004, Beijing, , China
Investigational Site Number 156016, Chengdu, , China
Investigational Site Number 156020, Chongqing, , China
Investigational Site Number 156021, Fuzhou, , China
Investigational Site Number 156008, Guangzhou, , China
Investigational Site Number 156010, Hangzhou, , China
Investigational Site Number 156011, Hangzhou, , China
Investigational Site Number 156009, Hangzhou, , China
Investigational Site Number 156015, Harbin, , China
Investigational Site Number 156012, Nanjing, , China
Investigational Site Number 156013, Nanjing, , China
Investigational Site Number 156006, Shanghai, , China
Investigational Site Number 156007, Shanghai, , China
Investigational Site Number 156014, Shenyang, , China
Investigational Site Number 156005, Tianjin, , China
Investigational Site Number 156019, Wuhan, , China
Investigational Site Number 156018, Wuhan, , China
Investigational Site Number 156017, Xi'An, , China
Investigational Site Number 344002, Hong Kong, , Hong Kong
Investigational Site Number 344001, Shatin, Nt, , Hong Kong
Investigational Site Number 392006, Amagasaki-Shi, , Japan
Investigational Site Number 392003, Bunkyo-Ku, , Japan
Investigational Site Number 392004, Bunkyo-Ku, , Japan
Investigational Site Number 392009, Gifu-Shi, , Japan
Investigational Site Number 392002, Kitaadachi-Gun, , Japan
Investigational Site Number 392001, Kobe-Shi, , Japan
Investigational Site Number 392005, Kochi-Shi, , Japan
Investigational Site Number 392007, Kumamoto-Shi, , Japan
Investigational Site Number 392008, Nagakute-Shi, , Japan
Investigational Site Number 392010, Takatsuki-Shi, , Japan
Investigational Site Number 702002, Singapore, , Singapore
Investigational Site Number 702001, Singapore, , Singapore
Investigational Site Number 158003, Taipai, , Taiwan
Investigational Site Number 158002, Taipei, , Taiwan
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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