A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
NCT ID: NCT04908787
Last Updated: 2025-09-11
Study Results
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Basic Information
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COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2021-06-11
2024-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BD0801+chemotherapy
BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
BD0801
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Topotecan
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
doxorubicin liposome
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
Placebo+chemotherapy
Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Placebo
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Topotecan
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
doxorubicin liposome
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
Interventions
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BD0801
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Placebo
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Topotecan
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
doxorubicin liposome
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
Eligibility Criteria
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Inclusion Criteria
* epithelial ovarian, fallopian tube or primary peritoneal cancer;
* platinum-resistant disease (disease progression within \<6 months of platinum therapy)
* Eastern Cooperative Oncology Group（ECOG）performance status of 0-1
Exclusion Criteria
* ovarian tumours with low malignant potential
* Received 1 line of systemic therapy for ovarian cancer following platinum resistance and/or \> 1 line of non-platinum systemic therapy prior to platinum resistance.
* prior radiotherapy to the pelvis or abdomen
18 Years
FEMALE
No
Sponsors
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Shanghai Xianxiang Medical Technology Co., Ltd.
INDUSTRY
Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of USTC West District,Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute, Guangxi Cancer Hospital&Medical University School&Cancer Center
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Nanjing Women and Children's Healthcare Hospital, Women's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nantong Cancer Hospital
Nantong, Jiangsu, China
Xuzhou Central Hospital(Southeast University Affiliated Hospital)
Xuzhou, Jiangsu, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Fukuang General Hospital of Liaoning Health Industry Group
Fushun, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Tianjin Center Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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SIM-63-OC-301
Identifier Type: -
Identifier Source: org_study_id
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