Clinical trial NCT06434610: A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Platinum-resistant Recurrent Ovarian Cancer
Lead sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Pharmaceuticals Holding Co., Ltd
First posted: 2024-05-30
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.


Eligibility criteria: 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 outcomes:
measure: Progression-free survival (PFS)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Approximately 2 years
measure: Duration of remission (DOR)
timeFrame: Approximately 5 years
measure: Overall Survival (OS)
timeFrame: Approximately 2 years
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
city: Changsha
country: China
facility: XiangYa Hospital CentralSouth University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer center
city: Shanghai
country: China
facility: The Obstetrics & Gynecology Hospital of Fudan University
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: Shananxi Provincial Cancer Hospital
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Yibin
country: China
facility: Yibin city second people's Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: