jRCT2031190241进行中（未招募）不适用
Phase II study of Darolutamide (ODM-201) in patients with androgen receptor-positive salivary gland carcinoma (Discovary study)
未提供0 个研究点目标入组 56 人开始时间: 2020年4月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 主要终点
- objective response rate(ORR) assessed by investigators
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 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.
结局指标
主要结局
objective response rate(ORR) assessed by investigators
Darolutamide monotherapy group
objective response rate(ORR) assessed by an Independent Review Committee
Darolutamide and Goserelin combination therapy group
次要结局
- ORR
研究者
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