NCT06434610招募中2 期
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., Ltd17 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 17
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
B013
Experimental
干预措施: B013 (Drug)
B013
Experimental
干预措施: Paclitaxel (Drug)
Placebo
Placebo Comparator
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Approximately 2 years
From the date of randomization to the date of progression disease or death , whichever occurred first.
次要结局
- Disease control rate (DCR)(Approximately 2 years)
- Objective response rate (ORR)(Approximately 2 years)
- Duration of remission (DOR)(Approximately 5 years)
- Overall Survival (OS)(Approximately 2 years)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Approximately 5 years)
研究者
研究点 (17)
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