NCT05694819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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 12
- 主要终点
- Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee
研究概览
简要总结
This study is an open-label phase 2 study to evaluate the safety and efficacy of Darolutamide monotherapy in patients with androgen receptor-positive salivary gland carcinoma. Moreover, this study will evaluate the safety and efficacy of Darolutamide and Goserelin combination in patients with androgen receptor-positive salivary gland carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Darolutamide monotherapy group:
- •Signed, written informed consent.
- •Patients older than 20 years.
- •Histologically confirmed any salivary duct carcinoma (SDC), adenocarcinoma (AC)(NOS), or Carcinoma ex pleomorphic adenoma.
- •Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
- •Presence of measurable or evaluable disease according to RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate organ or bone marrow function
- •Patients who agree to practice effective barrier contraception and refrain from sperm donation during the entire study treatment period and 3 months after the last dose of the study drug.
- •Darolutamide and Goserelin combination therapy group:
- •Signed, written informed consent.
- •Patients older than 20 years.
- •Histologically confirmed as androgen receptor-positive salivary gland carcinoma at the medical institution.
- •Histologically confirmed as salivary gland carcinoma at the medical institution.
- •Patients with locally recurrent(unresectable) or metastatic salivary gland carcinoma who are not applied for surgery or radiation treatment.
- •Presence of measurable or evaluable disease according to RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate organ or bone marrow function
- •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 the study drug.
排除标准
- •Darolutamide monotherapy group:
- •Histologically confirmed as androgen receptor-negative salivary gland carcinoma at a central laboratory.
- •Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, or LH-RH analogue.
- •Metastases in the brain/central nervous system (CNS).
- •Patients who are pregnant or breastfeeding.
- •Synchronous or metachronous malignancies.
- •Participant has a known history of HIV infection.
- •A positive test result for any of the followings:
- •HBsAg positive
- •HBsAb positive and hepatitis B virus (HBV)-DNA positive
- •HBcAb positive and HBV-DNA positive
- •Severe or uncontrolled concurrent heart disease or hypertension.
- •Inability to swallow oral medications.
- •Darolutamide and Goserelin combination therapy group:
- •Prior treatment with AR inhibitors, CYP17 enzyme inhibitors, LH-RH analogue, Sex Hormones, or Gonadotropin
- •Prior treatment with Darolutamide or Goserelin.
- •Metastases in the brain/CNS.
- •Patients who are pregnant or breastfeeding.
- •Synchronous or metachronous malignancies.
- •Participant has a known history of HIV infection.
- •A positive test result for any of the followings:
- •HBsAg positive
- •HBsAb positive and HBV-DNA positive
- •HBcAb positive and HBV-DNA positive
- •Severe or uncontrolled concurrent heart disease or hypertension.
- •Inability to administer Darolutamide or Goserelin.
研究组 & 干预措施
Darolutamide monotherapy
Experimental
Targeted patients: 24
干预措施: Darolutamide (Drug)
Darolutamide plus Goserelin
Experimental
Targeted patients: 32
干预措施: Darolutamide (Drug)
Darolutamide plus Goserelin
Experimental
Targeted patients: 32
干预措施: Goserelin (Drug)
结局指标
主要结局
Darolutamide and Goserelin combination therapy group: Objective response rate(ORR) assessed by an Independent Review Committee
时间窗: Up to 13 month
The proportion of patients with confirmed tumor response of CR or PR per RECIST 1.1, as assessed by an independent review committee
Darolutamide monotherapy group: Objective response rate(ORR) assessed by investigators
时间窗: Up to 13 month
The proportion of patients with confirmed tumor response of complete response (CR) or partial response (PR) per RECIST 1.1, as assessed by investigators
次要结局
- Best Overall Response (BOR)(Up to 13 month)
- Quality of Life assessed using the EuroQol-5Dimention-5Level (EQ-5D-5L) questionnaire(Up to 30 days after the last dose)
- Clinical Benefit Duration (CBD)(Up to 13 month)
- Overall Survival (OS)(Up to 13 month)
- Adverse events(Up to 30 days after the last dose)
- Darolutamide monotherapy group: ORR assessed by an Independent Review Committee(Up to 13 month)
- Comparison of androgen receptor (AR) test results in Darolutamide and Goserelin combination therapy group(Baseline)
- Disease Control Rate (DCR)(Up to 13 month)
- Progression-Free Survival (PFS)(Up to 13 month)
- Duration of Response (DOR)(Up to 13 month)
- Clinical Benefit Rate (CBR)(Up to 13 month)
- Darolutamide and Goserelin combination therapy group: ORR assessed by investigators(Up to 13 month)
- Positivity of Ki-67 in Darolutamide and Goserelin combination therapy group(Baseline)
研究者
Makoto Tahara
Chief, Department of Head and Neck Medical Oncology
National Cancer Center Hospital East
研究点 (12)
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