A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

Launched by SHANGHAI JIAOLIAN DRUG RESEARCH AND DEVELOPMENT CO., LTD · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called B013 when combined with another medication called paclitaxel for women with a specific type of ovarian cancer known as platinum-resistant recurrent ovarian cancer. This means the cancer has not responded to previous treatments that contain platinum. The researchers want to find out if this new combination is effective and safe for patients. The trial is currently recruiting participants who are female, aged between 18 and 75, and have certain health conditions that make them eligible.

To join the study, participants need to have a confirmed diagnosis of ovarian, fallopian tube, or primary peritoneal cancer, and they should have at least one measurable tumor. They also need to be in relatively good health, meaning they can perform daily activities with minimal assistance. Participants can expect regular check-ups and monitoring throughout the trial, and they will need to agree to use effective birth control if they are of childbearing age. It’s important to note that those with certain health issues or who have recently had other treatments may not be eligible. Overall, this trial offers the possibility of accessing a new treatment option while contributing to research that could help other women with similar conditions in the future.

Gender

FEMALE

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.