275
Participants
Start Date
September 10, 2021
Primary Completion Date
December 2, 2022
Study Completion Date
March 30, 2024
GB491+ Fulvestrant
"GB491: The dose of GB491 is 150 mg, BID, which should be taken with a meal. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.~Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial."
Placebo+Fulvestrant
"Placebo: The dose of Placebo is 150 mg, BID, which should be taken with a meal. The placebo is administered according to the patient's dose group until the progression of disease occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial.~Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles. Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side. The drug is administered according to the patient's dose group until the progression of disease or an intolerable toxicity occur or meet the criteria for termination of treatment or the patient withdraw informed consent or the sponsor discontinues the trial."
The Fourth Hospital of Hebei Medical University, Shijiazhuang
Beijing Chaoyang Hospital of Capital Medical University, Beijing
Cancer hospital Chinese Academy of Medical Sciences, Beijing
Chinese PLA General Hospital, Beijing
Beijing Tiantan Hospital , Capital Medical University, Beijing
Shengjing Hospital of China Medical University, Shenyang
Liaoning Cancer hospital & Institute, Shenyang
Jilin Cancer Hospital, Changchun
The Second Hospital of Jilin University, Changchun
Bethune First Hospital Of Jilin University, Changchun
Harbin Medcial Univercity cancer hospital, Haerbin
Zhongshan Hospital Fudan University, Shanghai
Jiangsu Province Hospital, Nanjing
Anhui Provincial Cancer Hospital, Hefei
The Second Hospital of Anhui Medical University, Hefei
The First Affiliated Hospital of Bengbu Medical College, Bengbu
Central Hospital Affiliated to Shandong First Medical University, Jinan
Shandong Provincial Qianfoshan Hospital, Jinan
Shandong Provincial Hospital, Jinan
Shandong Cancer Hospital, Jinan
Liaocheng People's Hospital, Liaocheng
Yantai Yuhuangding Hospital, Yantai
The Affiliated Hospital of Qingdao University, Qingdao
Taian City Central Hospital, Taian
Affiliated hospital of Jining Medical University, Jining
Tianjin Medical University Cancer Institute & Hospital, Tianjin
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
Zhejiang Cancer Hospital, Hangzhou
Jiangxi Provincial Hospital, Nanchang
Fujian Medical University Union Hospital, Fuzhou
First Affiliated Hospital of Xiamen University, Xiamen
Chongqing University Cancer Hospital, Chongqing
The First Affiliated Hospital of Chongqing Medical University, Chongqing
Chognqing University Three Gorges Hospital, Chongqing
Tongji Medical College of Huazhong University of Science and Technology, Wuhan
Renmin Hospital of Wuhan University, Wuhan
Hubei Cancer Hospital, Wuhan
Henan Cancer Hospital, Zhengzhou
The First Affiliated Hospital of Zhengzhou University, Zhengzhou
Affiliated hospital of Hebei University, Shijiazhuang
Sun Yat-sen University Cancer Center, Guangzhou
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou
Guangdong provincial TCM hospital, Guangzhou
Meizhou People's Hospital, Meizhou
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center Shenzhen Cancer Hospital, Shenzhen
The First people's hospital of Foshan, Foshan
Hainan General Hospital, Haikou
Hainan Third People's Hospital, Sanya
West China School of Medicine, Chengdu
The Third Affiliated Hospital of Kunming Medical University, Kunming
General Hospital of Ningxia Medical University, Yinchuan
The Affiliated hospital of Inner Mongolia Medical University, Hohhot
Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi
The first hospital of Shanxi Medical University, Taiyuan
Lead Sponsor
Genor Biopharma Co., Ltd.
INDUSTRY