Shanghai Jiaolian Drug Research and Development Co., Ltd
Phase
Phase 2
Started
2024-07-11
Last updated
2026-05-05
Condition(s) studied
Platinum-resistant Recurrent Ovarian Cancer
Investigational drug(s) / intervention(s)
B013PaclitaxelPlacebo
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.
Study summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subjects who voluntarily participate in this study and sign informed consent form;
2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
3. ECOG performance status of 0 or 1;
4. Expected survival \> 12 weeks;
5. The subject has at least one measurable lesion;
6. Normal function of major organs;
7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Exclusion Criteria:
1. Subjects who have received prescribed treatment previously;
2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
3. Subjects with known central nervous system metastasis and multiple bone metastasis;
4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
5. Have a history of other malignant tumors within 5 years before signing the informed consent;
6. Subjects with prescribed cardiovascular diseases;
7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
8. Had severe lung disease before randomization;
9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1;
10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
12. Subjects who are known to be allergic to any component of B013 or paclitaxel.
13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
14. Female subjects who are pregnant or breastfeeding;
15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
Primary outcome measure(s)
Progression-free survival (PFS) — Approximately 2 years From the date of randomization to the date of progression disease or death , whichever occurred first.
Trial sites (17)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
China
Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
China
Recruiting
XiangYa Hospital CentralSouth University
Changsha
China
Recruiting
Fujian Cancer Hospital
Fuzhou
China
Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
China
Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
China
Recruiting
Qilu Hospital of Shandong University
Jinan
China
Recruiting
Yunnan Cancer Hospital
Kunming
China
Recruiting
Guangxi Medical University Cancer Hospital
Nanning
China
Recruiting
Fudan University Shanghai Cancer center
Shanghai
China
Recruiting
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai
China
Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
China
Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
China
Recruiting
Shananxi Provincial Cancer Hospital
Xi'an
China
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
China
Recruiting
Yibin city second people's Hospital
Yibin
China
Recruiting
Henan Cancer Hospital
Zhengzhou
China
Recruiting
More Shanghai Jiaolian Drug Research and Development Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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