JPRN-jRCT2031190241进行中（未招募）2 期
Phase II study of Darolutamide (ODM-201) in patients with androgen receptor-positive salivary gland carcinoma - Discovary study
Tahara Makoto0 个研究点目标入组 56 人开始时间: 2020年3月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Darolutamide monotherapy group:
- •1.Signed, written informed consent.
- •2.Patients older than 20 years.
- •3.Histologically confirmed any of SDC, AC(NOS), or Carcinoma ex pleomorphic adenoma.
- •4.Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
- •5.Presence of measurable or evaluable disease according to RECIST v1.1
- •6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •7.Adequate organ or bone marrow function
- •8.Patients who agree to practice effective barrier contraception and refrain from sperm donation during the entire study treatment period and through 3 months after the last dose of study drug.
- •Darolutamide and Goserelin combination therapy group:
- •1.Signed, written informed consent.
- •2.Patients older than 20 years.
- •3.Histologically confirmed as androgen receptor-positive salivary gland carcinoma at the medical institution.
- •4.Histologically confirmed as salivary gland carcinoma at the medical institution.
- •5.Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
- •6.Presence of measurable or evaluable disease according to RECIST v1.1
- •7.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •8.Adequate organ or bone marrow function
- •9.Patients who agree to practice effective barrier contraception, refrain from sperm donation and stop breastfeeding during the entire study treatment period and through 3 months after the last dose of study drug.
排除标准
- •Darolutamide monotherapy group:
- •1.Histologically confirmed as androgen receptor-negative salivary gland carcinoma at central laboratory.
- •2.Prior treatment with AR inhibitors, CYP17 enzyme inhibitors or LH-RH analogue.
- •3.Metastases in the brain/CNS.
- •4.Patients who are pregnant or breastfeeding.
- •5.Synchronous or metachronous malignancies.
- •6.Participant has a known history of HIV infection.
- •7.A positive test result for any of the followings:
- •-HBsAg positive
- •-HBsAb positive and HBV-DNA positive
- •-HBcAb positive and HBV-DNA positive
- •8.Severe or uncontrolled concurrent heart disease or hypertension.
- •9.Inability to swallow oral medications.
- •Darolutamide and Goserelin combination therapy group:
- •1.Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex Hormones or Gonadotropin
- •2.Prior treatment with Darolutamide or Goserelin.
- •3.Metastases in the brain/CNS.
- •4.Patients who are pregnant or breastfeeding.
- •5.Synchronous or metachronous malignancies.
- •6.Participant has a known history of HIV infection.
- •7.A positive test result for any of the followings:
- •-HBsAg positive
- •-HBsAb positive and HBV-DNA positive
- •-HBcAb positive and HBV-DNA positive
- •8.Severe or uncontrolled concurrent heart disease or hypertension.
- •9.Inability to administering Darolutamide or Goserelin.
研究者
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