2022-500745-24-00招募中3 期
A randomized phase II trial on the addition of dutasteride to combined androgen blockade therapy versus combined androgen blockade therapy alone in patients with recurrent and/or metastatic salivary duct carcinoma – DUCT study
Stichting Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年8月11日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR) defined as proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by Investigator according to RECIST v1.1
研究概览
简要总结
To determine the efficacy of dutasteride in combination with combined androgen blockade therapy in patients with recurrent and/or metastatic salivary duct carcinoma
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Cohort B
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Pathologically/histologically proven diagnosis of (incurable) AR+ R/M salivary duct carcinoma
- •Adequate cardiac function
- •AR positive diseases (strong expression in at least 1% of nuclei of neoplastic cells based on central IHC review)
- •Measurable disease per RECIST version 1.1 at baseline
- •Age ≥ 18 years
- •Written informed consent must be given according to national/local regulation
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate bone marrow function: (WBC ≥ 3.5x10^9 /L; Absolute neutrophil count (ANC) ≥ 1.5x10^9/L; Hemoglobin ≥ 6.20 mmol/L; Platelet count ≥ 100x10^9/L)
- •Adequate liver function: (Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) OR ≤ 5.0 times ULN for patients with liver metastases; Bilirubin ≤ 1.5 times ULN. For patients known with Gilbert’s Syndrome ≤ 3.0 times ULN is permitted)
- •Adequate renal function: (Serum creatinine level ≤ 1.5 times ULN or calculated creatinine clearance ≥ 30 mL/min based on CKD-EPI-GFR)
排除标准
- •Patients with history of allergic reactions attributed to compounds of similar chemical or biological composition to goserelin, bicalutamide or dutasteride
- •Concurrent treatment with any other anti-cancer therapy within the last 4 weeks before inclusion
- •Curative radiation therapy within the last 4 weeks before inclusion or palliative radiation therapy 1 week before start of study
- •Any condition which, in the opinion of the investigator, would preclude participation in this clinical study
- •Patients with peanut or soy allergy (dutasteride capsules contain lecithin which may contain soy oil)
- •Patients who do not have adequate swallowing capacity
- •Patients familiar with Long QT-syndrome (LQTS)
- •Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
- •Patients that are pregnant or lactating
- •Patients with uncontrolled illness including: Cardiovascular disorders, including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias; Uncontrolled hypertension (defined as sustained systolic BP > 160 mm Hg, or diastolic BP > 100 mm Hg. Unless evidence of white-coat hypertension), Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion; Serious active infections .
- •Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation
- •Concomitant (or within 6 months before inclusion) administration of any 5-alpha reductase inhibitor, i.e. dutasteride or finasteride
结局指标
主要结局
Overall response rate (ORR) defined as proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by Investigator according to RECIST v1.1
Overall response rate (ORR) defined as proportion of participants who have a confirmed complete response (CR) or partial response (PR) determined by Investigator according to RECIST v1.1
Duration of Response (DoR), defined as the time from first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed until documented progressive disease (PD) determined by Investigator per RECIST v1.1 or death from any cause, whichever occurs first
Duration of Response (DoR), defined as the time from first tumor assessment at which the overall response was recorded as PR or CR that is subsequently confirmed until documented progressive disease (PD) determined by Investigator per RECIST v1.1 or death from any cause, whichever occurs first
次要结局
- Quality of life (QoL) assessments according to approved EORTC (QLQ-C30, QLQ-H&N35, QLQ-SHQ22) and VAS questionnaires
- Circulating tumor DNA (ctDNA) and serum testosterone
- Progression free survival (PFS), defined as the time from study enrolment until the date of first documented disease progression by Investigator as per RECIST v1.1, or death due to any cause, whichever occurs first
- Overall survival (OS), defined as the time from study enrolment to the date of death due to any cause
- Clinical benefit rate (CBR) including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator as per RECIST v1.1
- Incidence of SAE’s according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- AR, AR splice variants and SRD5A1/SRD5A2 mRNA expression on baseline and post-treatment tumor tissue samples
- Various subsets of immune cells. Including different panels, but not limited to, a lymphocyte panel, a dendritic cell panel, a checkpoint panel, and a myeloid-derived suppressor cell panel
研究者
RTC clincial studies
Scientific
Stichting Radboud University Medical Center
研究点 (1)
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