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临床试验/jRCT2031260005
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

发起方
未提供

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