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A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
Sponsor: 1Globe Health Institute LLC
Summary
This is a Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure
Official title: A Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2018-10-25
Completion Date
2025-09
Last Updated
2024-04-03
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (38)
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijng Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
People's Hospital of Hunan Province
Changsha, Hunan, China
The Third Xianya Hospital of Central South University
Changsha, Hunan, China
The 81 Hospital of the Chinese People Liberation Army
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
East Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute Hospital
Tianjin, Tianjin Municipality, China
Sir Run Shaw Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Institut de Cancerologie de Lorraine
Bourgogne, France
Unité de Recherche Clinique en Cancérologie, Institut de cancérologie et d'hématologie
Brest, France
Centre Antoine Lacassagne
Nice, France
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario HMN Sanchinarro
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain