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

RecruitingPhase 2Ages 18 Years - 75 YearsFemaleShanghai Jiaolian Drug Research and Development Cโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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๏ผ› 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.
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What it tests

  • B013
  • Paclitaxel
  • Placebo
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Where

17 sites
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
Qilu Hospital of Shandong University
Jinan, China
Yunnan Cancer Hospital
Kunming, China

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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