336
Participants
Start Date
October 25, 2018
Primary Completion Date
March 31, 2025
Study Completion Date
September 30, 2025
GB201
GB201 will be administered orally, twice daily, with doses separated by approximately 8-12 hours. GB201 administration will begin 2-5 days prior to the first infusion of paclitaxel and low-dose gemcitabine
Paclitaxel
Paclitaxel 80 mg/m\^2 will be administered intravenously starting on Day 1 of Cycle 1. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle
Gemcitabine
Low-dose gemcitabine 600 mg/m\^2 will be administered intravenously following completion of paclitaxel infusion. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle.
Standard of care treatment options
Patients will receive one of the standard of care treatment options assigned by the Investigator for each patient prior to starting protocol treatment, including Gemcitabine, capecitabine, 5-FU/LV, Onivyde plus 5-FU/LV (if Onivyde is available in the country/region) or best supportive care (BSC).
RECRUITING
Anhui Provincial Cancer Hospital, Hefei
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The First Affiliated Hospital of Anhui Medical University, Hefei
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Beijng Cancer Hospital, Beijing
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Cancer Hospital Chinese Academy of Medical Sciences, Beijing
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Chinese PLA General Hospital, Beijing
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Fujian Medical University Union Hospital, Fuzhou
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Fujian Provincial Cancer Hospital, Fuzhou
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Guangdong General Hospital, Guangzhou
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SUN YAT-SEN University Cancer Center, Guangzhou
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Harbin Medical University Cancer Hospital, Harbin
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The First Affiliated Hospital of Xinxiang Medical University, Xinxiang
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Henan Cancer Hospital, Zhengzhou
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The First Affiliated Hospital of Zhengzhou University, Zhengzhou
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Union Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan
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People's Hospital of Hunan Province, Changsha
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The Third Xianya Hospital of Central South University, Changsha
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The 81 Hospital of the Chinese People Liberation Army, Nanjing
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Nantong Tumor Hospital, Nantong
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The First Bethune Hospital of Jilin University, Changchun
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The Second Hospital of Dalian Medical University, Dalian
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Shandong Cancer Hospital, Jinan
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East Hospital of Tongji University, Shanghai
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Fudan University Shanghai Cancer Center, Shanghai
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Huashan Hospital Fudan University, Shanghai
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Shanghai General Hospital, Shanghai
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Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai
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Shanxi Provincial Cancer Hospital, Taiyuan
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Tianjin Medical University Cancer Institute Hospital, Tianjin
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Sir Run Shaw Hospital School of Medicine Zhejiang University, Hangzhou
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The First Affiliated Hospital Zhejiang University, Hangzhou
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Zhejiang Cancer Hospital, Hangzhou
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The First Hospital of Jiaxing, Jiaxing
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Institut de Cancerologie de Lorraine, Bourgogne
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Unité de Recherche Clinique en Cancérologie, Institut de cancérologie et d'hématologie, Brest
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Centre Antoine Lacassagne, Nice
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Hospital Universitari Vall d'Hebron, Barcelona
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Hospital Universitario HMN Sanchinarro, Madrid
RECRUITING
Hospital Universitario La Paz, Madrid
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INDUSTRY