NCT06141265招募中2 期
Chemotherapy Combined With Bevacizumab Followed by Niraparib Monotherapy in Newly Diagnostic Advanced Ovarian Cancer With HRD Positive : A Perspective, Multicenter, Single-arm Phase II Trial
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2023年11月1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
- 116
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) Rate at 24 months (PFS24)
研究概览
简要总结
This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC), including primary peritoneal and/or fallopian tube tumors, following response to front-line chemotherapy in combination with bevacizumab. A total of 116 patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The written informed consent form shall be signed before proceeding with any study-related procedure.
- •Participants shall be a female, aged 18 years or older.
- •Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma。
- •FIGO staging is Stage III or IV.
- •Patients who have undergone primary tumor reductive surgery or intermittent tumor reductive surgery (patients who have used neoadjuvant therapy), regardless of postoperative residual lesion status
- •Participants must have received, prior to enrollment, a minimum of 2 cycles of bevacizumab in combination with platinum-based chemotherapy.
- •Participants must have completed front-line, platinum-based chemotherapy with CR, PR, or NED assessed by RECIST v1.
- •Participant must have either CA-125 in the normal range or CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir).
- •Participants must have first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy.
- •Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCA mutation prior to enrollment.
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) score ≤
- •Organ function is in good condition, including: Hemoglobin ≥100 g/L; White blood cell count ≥3×10^9/L; Neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin is not more than 1.5 times the normal upper limit; ALK, AST and ALT are not more than 2.5 times their normal upper limit, and with existence of hepatic metastasis, these values must not be more than 5 times their normal upper limit; Serum creatinine is not more than 1.5 times the normal upper limit.
排除标准
- •Histopathological types other than high-grade ovarian/tubal/peritoneal cancer or metastatic ovarian cancer.
- •Receipt of other targeted drugs as maintenance therapy, excluding PARP inhibitors.
- •Concurrent severe respiratory or hematologic disorders, poorly controlled diabetes, uncontrolled hypertension of Grade 2 or higher, NYHA Class III or higher congestive heart failure, unstable angina, recent myocardial infarction within the past 6 months, or other circulatory system diseases.
- •Any other significant complications or functional impairments in organ systems, as determined by the investigator, that may affect the safety of the participant or interfere with the evaluation of the investigational drug.
- •Expected survival less than 3 months.
- •Other than ovarian cancer, the participant has been diagnosed a second primary tumor within the past 2 years and currently undergoing treatment.
研究组 & 干预措施
Niraparib
Experimental
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
干预措施: Niraparib (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Rate at 24 months (PFS24)
时间窗: At 24 months
PFS rate at 24 months is defined as the percentage of participants who have not progressed or died within 24 months after niraparib treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method.
次要结局
- Progression Free Survival (PFS) Rate at 12 months (PFS12)(At 12 months)
- Time to First Subsequent Therapy (TFST)(up to 36 months)
- Time to Second Subsequent Therapy (TSST)(up to 48 months)
- Median Progression Free Survival（mPFS）(up to 36 months)
研究者
Hong Zheng
M.D.
Peking University Cancer Hospital & Institute
研究点 (1)
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