A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
A Open-label, Multicenter Phase II Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Jiangsu
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Changzhou、Jiangsu、中国、213003
- 尚未招聘
- The First People's Hospital of Changzhou
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接触:
- Weiqing Zhao, Doctor
- 邮箱:zwq7860@163.com
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首席研究员:
- Weiqing Zhao, Doctor
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Nanjing、Jiangsu、中国
- 尚未招聘
- Nanjing Drum Tower Hospital
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接触:
- Huaijun Zhou, Doctor
- 邮箱:zhouhj2007@126.com
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首席研究员:
- Huaijun Zhou, Doctor
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Shanghai
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Shanghai、Shanghai、中国、200032
- 招聘中
- Fudan University Shanghai Cancer Center
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接触:
- Xiaohua Wu, Doctor
- 邮箱:wu.xh@fudan.edu.cn
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首席研究员:
- Xiaohua Wu, Doctor
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Shanghai、Shanghai、中国、200090
- 尚未招聘
- Gynecology Hospital of Fudan University
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接触:
- Xiaojun Chen, Doctor
- 邮箱:cxjlhjj@163.com
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首席研究员:
- Xiaojun Chen, Doctor
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Zhejiang
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Hangzhou、Zhejiang、中国、310016
- 尚未招聘
- Sir Run Run Shaw Hospital Medical School Zhejiang University
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接触:
- Xian Wang, Doctor
- 邮箱:yedw@srrsh.com
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首席研究员:
- Xian Wang, Doctor
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1. Pathologically confirmed malignant gynecological neoplasm. 2. Has PIK3CA and/or PIK3R1/2 Gene-altered. 3.Unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion.
4.Failed with standard treatment or has no effective treatment. 5. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1, Life expectancy ≥ 3 months.
6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
7.Understood and signed an informed consent form.
Exclusion Criteria:
1.Has untreated or active central nervous system metastases. 2.Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
3. Insufficient hematopoietic function of bone marrow. 4. Dysfunction of liver and kidney. 5. Bleeding risk. 6. Dysfunction of gastrointestinal tract. 7.Dysfunction of heart and cerebral vessels. 8.Has received PI3K, AKT, mTOR inhibitor. 9.Has participated in other clinical trails within 30 days. 10. Has received surgery, or unhealed wounds within 4 weeks before the first administration.
11. Has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction.
12. The patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid <10 mg, except metacortandracin or other therapeutic hormones and so on).
13. Has active infections. 14. Has human immunodeficiency virus (HIV). 15. Pregnant or lactating women. 16. Has psychotropic substances abuse or a mental disorder. 17. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
18. Patient's compliance is inadequate.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:TQ-B3525 tablet
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TQ-B3525 tablet administered orally once a day.
Each cycle is 28 days.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall response rate (ORR) assessed by Independent Review Committee
大体时间:up to 48 weeks
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Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
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up to 48 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall response rate (ORR) assessed by Investigator
大体时间:up to 48 weeks
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Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
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up to 48 weeks
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疾病控制率(DCR)
大体时间:长达 48 周
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达到完全反应 (CR) 和部分反应 (PR) 以及疾病稳定 (SD) 的受试者百分比。
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长达 48 周
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Duration of disease remission (DOR)
大体时间:up to 48 weeks
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The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).
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up to 48 weeks
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Progression-free survival (PFS)
大体时间:up to 48 weeks
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PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
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up to 48 weeks
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Overall survival (OS)
大体时间:up to 72 weeks
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OS defined as the time from the first dose to death from any cause.
Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
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up to 72 weeks
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DOR rate (≥ 6 months) (percentage of subjects with disease remission duration ≥ 6 months)
大体时间:up to 48 weeks
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The percentage of subjects achieving CR or PR was recorded for the first time to 6 months after the first time of objective tumor progression or death due to any cause (whichever occurred first) was recorded.
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up to 48 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
TQ-B3525 tablet的临床试验
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.未知
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.招聘中
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.未知
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.终止