Trial Title:
A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
NCT ID:
NCT06434610
Condition:
Platinum-resistant Recurrent Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
B013
Description:
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.
Arm group label:
B013
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel: 80 mg/m^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
Arm group label:
B013
Arm group label:
Placebo
Intervention type:
Drug
Intervention name:
Placebo
Description:
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.
Arm group label:
Placebo
Summary:
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent
ovarian cancer.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Zheng
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical University
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongli Liu
Facility:
Name:
XiangYa Hospital CentralSouth University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Zhang
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Xie
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunxian Rao
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianqing Zhu
Facility:
Name:
Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Chen
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Kun Song
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongying Yang
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Contact:
Last name:
He Wang
Facility:
Name:
Fudan University Shanghai Cancer center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Wu
Facility:
Name:
The Obstetrics & Gynecology Hospital of Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Lu
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Danbo Wang
Facility:
Name:
The Second Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianghua Huang
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Guiling Li
Facility:
Name:
Shananxi Provincial Cancer Hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoqing Wang
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianfa Lan
Facility:
Name:
Yibin city second people's Hospital
Address:
City:
Yibin
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaijian Lei
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanlin Luo
Start date:
July 11, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Jiaolian Drug Research and Development Co., Ltd
Agency class:
Industry
Collaborator:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Jiaolian Drug Research and Development Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434610
