jRCT2031260005
招募中
不适用
A Phase I study to determine the safety and tolerability of BI 3820768 in patients with advanced relapsed or refractory germ cell tumours, endometrial cancer, or ovarian cancer
未提供0 个研究点目标入组 187 人开始时间: 待定
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 187
概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
入选标准
- •Patient must be >=18 years of age at the time of signature on the informed consent forms.
- •For patients with endometrial cancer and ovarian cancer who signed and dated the informed consent form for target genetic testing and confirmed positive test result
- •For patients who signed and dated the informed consent form for trial participation.
- •Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour, endometrial cancer or ovarian cancer, and patients who are diagnosed as advanced, relapsed or refractory disease.
- •Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options.
- •Patients without significant impairment of the general condition and with adequate organ function
排除标准
- •Patient with a history of a major surgery within 28 days prior to the first dose of BI
- •Previous or concomitant malignancies other than the specific one treated in this trial within the past 3 years.
- •Patient with known leptomeningeal disease or spinal cord compression due to disease.
- •Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to the first dose of trial medication.
- •Patients who are infected with hepatitis B virus or hepatitis C virus, or have a history of such infection, and are deemed ineligible for study participation based on specific test results.
研究者
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