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New treatment option for Platinum-resistant Recurrent Ovarian Cancer
Official title A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
ClinicalTrials.gov ID: NCT06434610
What this study is testing
What is B013?
B013 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for platinum-resistant recurrent ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- people who voluntarily participate in this study and sign informed consent form;
- Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum...
- ECOG performance status of 0 or 1；
- Expected survival \> 12 weeks;
- The subject has at least one measurable lesion;
You likely can't join if
- people who have received prescribed treatment previously;
- people who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
- people with known central nervous system metastasis and multiple bone metastasis;
- people who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had...
- Have a history of other malignant tumors within 5 years before signing the informed consent;
- people with prescribed cardiovascular diseases;
See the full eligibility criteria
- people who voluntarily participate in this study and sign informed consent form;
- Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
- ECOG performance status of 0 or 1；
- Expected survival \> 12 weeks;
- The subject has at least one measurable lesion;
- Normal function of major organs;
- The fertile people agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
- people who have received prescribed treatment previously;
- people who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
- people with known central nervous system metastasis and multiple bone metastasis;
- people 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;
- Have a history of other malignant tumors within 5 years before signing the informed consent;
- people with prescribed cardiovascular diseases;
- people with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
- Had severe lung disease before randomization;
- Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1;
- people who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
- people who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
- people who are known to be allergic to any component of B013 or paclitaxel.
- people with a known history of substance abuse, alcohol or drug use; people with a known history of neurological or psychiatric disorders;
- Female people who are pregnant or breastfeeding;
- Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Bengbu, China
- Changsha, China
- Fuzhou, China
- Guangzhou, China
- Jinan, China
- Kunming, China
- Nanning, China
- Shanghai, China
- Shijiazhuang, China
- Wuhan, China
- Xi'an, China
- Xiamen, China
- Yibin, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Bengbu, China; Changsha, China; Fuzhou, China; Guangzhou, China; Jinan, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.