Combining B013 with Paclitaxel for treating 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.

This study is testing if a new drug called B013, when combined with Paclitaxel, can help people with platinum-resistant recurrent ovarian cancer feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd (Industry-sponsored)
• Locations: 17 sites (Beijing and 16 other locations)
• Trial ID: NCT06434610 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of the drug B013 in combination with Paclitaxel for patients suffering from platinum-resistant recurrent ovarian cancer. Participants will receive either the combination treatment or a placebo, and their responses will be monitored to determine the effectiveness of the therapy. The study aims to enroll patients who meet specific criteria, including having measurable lesions and a performance status of 0 or 1. The goal is to provide a new treatment option for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed platinum-resistant recurrent ovarian, fallopian tube, or primary peritoneal cancer who have a performance status of 0 or 1.

Not a fit: Patients with central nervous system metastasis or those currently using anti-tumor traditional Chinese medicines may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with limited choices due to platinum resistance.

How similar studies have performed: While there have been studies on treatments for ovarian cancer, the specific combination of B013 and Paclitaxel in this context is novel and has not been extensively tested.

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.

Where this trial is running

Beijing and 16 other locations

• Beijing Cancer Hospital — Beijing, China (Recruiting)
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, China (Recruiting)
• XiangYa Hospital CentralSouth University — Changsha, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)
• Cancer Hospital of Shandong First Medical University — Jinan, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, China (Recruiting)
• Fudan University Shanghai Cancer center — Shanghai, China (Recruiting)
• The Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (Recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• Shananxi Provincial Cancer Hospital — Xi'an, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (Recruiting)
• Yibin city second people's Hospital — Yibin, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Xiaohua Wu

Conditions Platinum-resistant Recurrent Ovarian Cancer