A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment in Patients With Platinum-sensitive Relapsed Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 265
- 试验地点
- 27
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively referred to as relapsed ovarian cancer).The evaluation will be divided into two stages: Stage I will be conducted in all patients, and if the predetermined statistically significant difference is not reached, the trial will continue to extend to Stage II during which evaluation will be performed in gBRCA mutation-positive ovarian cancer patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older female.
- •High-grade serous or dominantly high-grade serous ovarian cancer
- •The subject shall have received two lines of platinum-containing chemotherapy, complete response [CR] or partial response [PR] after first-line platinum-containing chemotherapy, and after received at least 4 cycles of platinum-containing (must be carboplatin or cisplatin or nedaplatin) in second-line platinum-containing chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Patients who have undergone ascites drainage with the last two cycles of the last chemotherapy regimen prior to enrollment.
- •Symptomatic brain metastases or leptomeningeal metastases that have not been controlled.
- •Patients who have been diagnosed previously or currently with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
研究组 & 干预措施
Placebo
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
干预措施: Placebos (Drug)
ZL-2306
The starting dose is 300 mg or 200 mg based on patient's body weight.
干预措施: ZL-2306(nirapairb) (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 35 months
It is defined as the time from randomization to progressive disease or death due to various causes, whichever occurs first. Progressive disease will be determined by the Independent Central Imaging Review according to standard RECIST 1.1.
次要结局
- Time to first subsequent anti-cancer treatment (TFST)(35 months)
- Overall survival (OS)(35 months)
- Chemotherapy-free interval (CFI)(35 months)