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Brief Title: A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer
Official Title: A Phase III, Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination With FOLFIRI Versus Napabucasin in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)
Study ID: NCT03522649
Brief Summary: This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. For patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with FOLFIRI to patients randomized to Arm 1.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Beijng Cancer Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat - sen University, Guangzhou, Guangdong, China
Forth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
The 81 Hospital of the Chinese People's Liberation Army, Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Jiangsu Provence Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Bethune Hospital of Jilin University, Changchun, Jilin, China
Liaoning Provincial Cancer Hospital, Shenyang, Liaoning, China
Shandong Cancer Hospital, Jinan, Shandong, China
The Affiliated Hospital Qingdao University, Qingdao, Shandong, China
Shanghai General Hospital, Shanghai, Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Shanghai East Hospital, Shanghai, Shanghai, China
Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
The First Affiliated Hospital of Xi' AnJiaotong University, Xi'an, Shanxi, China
The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China
Sir Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China