A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
NCT ID: NCT06434610
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2024-07-11
2026-12-31
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
DOUBLE
Study Groups
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B013
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Shanghai Jiaolian Drug Research and Development Co., Ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Hong Zheng
Role: primary
Hongli Liu
Role: primary
Yu Zhang
Role: primary
Rong Xie
Role: primary
Qunxian Rao
Role: primary
Liang Chen
Role: primary
Kun Song
Role: primary
Hongying Yang
Role: primary
He Wang
Role: primary
Xiaohua Wu
Role: primary
Xin Lu
Role: primary
Xianghua Huang
Role: primary
Guiling Li
Role: primary
Guoqing Wang
Role: primary
Jianfa Lan
Role: primary
Kaijian Lei
Role: primary
Yanlin Luo
Role: primary
Other Identifiers
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SPH-B013-201
Identifier Type: -
Identifier Source: org_study_id
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