A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
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.
1 other identifier
interventional
90
1 country
17
Brief Summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2024
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 5, 2026
April 1, 2026
2.5 years
May 23, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
From the date of randomization to the date of progression disease or death , whichever occurred first.
Approximately 2 years
Secondary Outcomes (5)
Objective response rate (ORR)
Approximately 2 years
Disease control rate (DCR)
Approximately 2 years
Duration of remission (DOR)
Approximately 5 years
Overall Survival (OS)
Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Approximately 5 years
Study Arms (2)
B013
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
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
You may qualify if:
- Subjects who voluntarily participate in this study and sign informed consent form;
- Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
- ECOG performance status of 0 or 1；
- Expected survival \> 12 weeks;
- The subject has at least one measurable lesion;
- Normal function of major organs;
- The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
You may not qualify if:
- Subjects who have received prescribed treatment previously;
- Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
- Subjects with known central nervous system metastasis and multiple bone metastasis;
- 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;
- Have a history of other malignant tumors within 5 years before signing the informed consent;
- Subjects with prescribed cardiovascular diseases;
- Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
- Had severe lung disease before randomization;
- Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1;
- Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
- Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
- Subjects who are known to be allergic to any component of B013 or paclitaxel.
- Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
- Female subjects who are pregnant or breastfeeding;
- Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2024
First Posted
May 30, 2024
Study Start
July 11, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04