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A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-07-11
Completion Date
2026-12-31
Last Updated
2025-01-27
Healthy Volunteers
No
Interventions
B013
B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Paclitaxel
Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
Placebo
Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Locations (17)
Beijing Cancer Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
XiangYa Hospital CentralSouth University
Changsha, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Qilu Hospital of Shandong University
Jinan, China
Yunnan Cancer Hospital
Kunming, China
Guangxi Medical University Cancer Hospital
Nanning, China
Fudan University Shanghai Cancer center
Shanghai, China
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Shananxi Provincial Cancer Hospital
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Yibin city second people's Hospital
Yibin, China
Henan Cancer Hospital
Zhengzhou, China