Status:
COMPLETED
A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Shanghai Xianxiang Medical Technology Co., Ltd.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resis...
Eligibility Criteria
Inclusion
- female patients, \>/=18 years of age;
- 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
- non-epithelial tumours
- 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
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2024
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT04908787
Start Date
June 11 2021
End Date
October 11 2024
Last Update
September 11 2025
Active Locations (55)
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1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
2
The First Affiliated Hospital of USTC West District,Anhui Provincial Cancer Hospital
Hefei, Anhui, China
3
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
4
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, China