SC10914 Monotherapy for gBRCA1/2 Mutation Advanced Ovarian Cancer Patients With at Least 2 Prior Lines of Chemotherapy: a Single Arm, Open Label, Multicenter Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
A phase II, multicenter, open-label, single-arm study to evaluate the efficacy, safety and pharmacokinetics of SC10914 in subjects with gBRCA1/2 mutated advanced ovarian cancer in china.
详细描述
A total of 104 subjects with gBRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety and PK profile of SC10914.
The subjects oral administration SC10914 tablets 400mg on an empty stomach, three times a day, for 28 consecutive days as a treatment cycle, until disease progression (PD) or the toxicity was intolerable. PK blood samples are planned to be collected for each enrolled subject on C1D28 visit.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent voluntarily;
- •≥18 years old;
- •Histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma);
- •gBRCA1/2 mutation positive;
- •Had recived at least 2 prior lines of chemotherapy;
- •Platinum sensitive patients;
- •The last line of therapy befor enrollment failed；
- •Had at least one measurable lesion.
排除标准
- •Any previous treatment with PARP inhibitor;
- •Symptomatic brain metastases;
- •Large amount of fluid in the third gap；
- •Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC<1.5×10^9/L PLT<100×10^9/L Hb<100g/L TBIL>1.5×ULN ALT, AST>2.5×ULN (without liver metastases) or ALT, AST>5×ULN (with liver metastases) Cr >1.5×ULN
研究组 & 干预措施
SC10914 group
干预措施: SC10914 (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: up to 100 weeks (estimated)
assessed by the independent imaging assessment committee (recist1.1)
次要结局
未报告次要终点