A Study of B013 in Combination With Paclitaxel in Patients With 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.
Shanghai Jiaolian Drug Research and Development Co., Ltd
90 participants
Jul 11, 2024
INTERVENTIONAL
Conditions
Summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Eligibility
Inclusion Criteria7
- Subjects 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 subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Exclusion Criteria15
- Subjects who have received prescribed treatment previously;
- Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
- Subjects with known central nervous system metastasis and multiple bone metastasis;
- 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;
- Have a history of other malignant tumors within 5 years before signing the informed consent;
- Subjects with prescribed cardiovascular diseases;
- Subjects 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;
- Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
- Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
- Subjects who are known to be allergic to any component of B013 or paclitaxel.
- Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
- Female subjects who are pregnant or breastfeeding;
- Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
Interventions
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.
Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
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.
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06434610