NCT04814108已完成2 期
A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc56 个研究点 分布在 3 个国家目标入组 92 人开始时间: 2021年7月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 56
- 主要终点
- Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR
研究概览
简要总结
This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).
详细描述
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females ≥18 years of age at the time of informed consent.
- •Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject.
- •Subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible.
- •Subjects with carcinosarcomas (even if there is a serous component) are not eligible.
- •Measurable disease per RECIST Guideline Version 1.1
- •Required prior therapy for endometrial cancer:
- •Treatment with a platinum-based chemotherapy regimen.
- •Treatment with a PD-(L)1 inhibitor
- •Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.
- •Adequate hematologic and organ function
排除标准
- •Any of the following treatment interventions within the specified time frame prior to C1D1:
- •Major surgery within 28 days
- •Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).
- •Radiation therapy within 21 days;
- •Autologous or allogeneic stem cell transplant within 3 months.
- •Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
- •Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.
- •A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
研究组 & 干预措施
Azenosertib Single Agent
Experimental
Azenosertib (ZN-c3) taken orally with food
干预措施: Azenosertib (Drug)
结局指标
主要结局
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR
时间窗: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC
Frequency and severity of TEAEs
时间窗: 2 years
To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.
次要结局
- Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.(2 years)
- Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.(2 years)
- Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.(2 years)
- Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.(2 years)
- Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.(2 years)
研究者
研究点 (56)
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