A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
- Conditions
- Platinum-resistant Recurrent Ovarian Cancer
- Interventions
- Registration Number
- NCT06434610
- Lead Sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Brief Summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B013 B013 - B013 Paclitaxel - Placebo Placebo - Placebo Paclitaxel -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) Approximately 2 years From the date of randomization to the date of progression disease or death , whichever occurred first.
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) Approximately 2 years DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
Objective response rate (ORR) Approximately 2 years Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Duration of remission (DOR) Approximately 5 years DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
Overall Survival (OS) Approximately 2 years Determination of the overall survival times of all participants.
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Approximately 5 years The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0.
Trial Locations
- 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
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
Fudan University Shanghai Cancer center
🇨🇳Shanghai, China
Yunnan Cancer Hospital
🇨🇳Kunming, 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