NCT05895864招募中2 期
Utidelone Treated for the Recurrent or Metastatic Urothelial Carcinoma After Prior Chemotherapy: a Open-label, Multicenter Phase II Study (UTRUST)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年6月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study is a open-label, multicenter, phase II study to evaluate the efficacy and safety of utidelone in the recurrent or metastatic urothelial carcinoma after prior chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 years
- •Histologically confirmed urothelial carcinoma (pelvis, ureter, bladder, urethra)
- •Recurrent (unresectable) or metastatic urothelial carcinoma, Patients with primary urothelial carcinoma, mixed with other tissue components, failed or intolerant to standard treatment, and failed to receive neoadjuvant chemotherapy combined with immunotherapy for 12 months were allowed
- •At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
- •Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- •The results of patient's laboratory biochemistry tests are as follows:
- •Normal blood routine within 1 week before enrollment (no blood transfusion or hematopoietic stimulating factor therapy within 14 days) :Hemoglobin(Hb) ≥ 90g/L; Neutrophil count (ANC) > 1.5x109 / L; Platelet count (PLT) ≥ 75×109/L
- •Renal function: serum creatinine ≤ normal upper limit (ULN)
- •Liver and renal function:
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)≤ 3 x ULN, total bilirubin ≤1.5 x ULN, Serum creatinine :≤1.5× ULN or creatinine clearance (Ccr)≥50 ml/min
- •Life expectancy ≥ 3 months
- •Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 3 months after the last day of treatment.
- •Females of childbearing potential must have a negative serum pregnancy test at screening and must agree to use double barrier contraception, oral contraceptives, or avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.
排除标准
- •Pregnant or lactating women
- •Suitable for radical means with a chance of cure
- •Patients had received radiation therapy, TKI, or immune checkpoint inhibitor within 2 weeks after the initiation of the study
- •Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug
- •Received an investigational agent, chemotherapy, biological therapy, hormonal therapy, targeted therapy, or radiotherapy within 30 days prior to commencing study treatment, or have not recovered from all treatment-related toxicities to Common Toxicity Criteria (CTC) Grade less than or equal to 1, except for alopecia.CTCAE v.5.0 Grade greater than or equal to 2 peripheral neuropathy;
- •Known active infection with human immunodeficiency virus (HIV), hepatitis B, virus (HBV) or hepatitis C; virus (HCV)
- •Prior allergies to castor oil
- •Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
- •Patients with mental disorders or poor compliance
- •A history of severe cardiovascular and cerebrovascular diseases, including but not limited to severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree II-III atrioventricular block, etc. The mean QTcF obtained from three 12-lead ECG examinations at rest was >470ms. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular events occurred within 6 months before the first dose of dose. Clinically uncontrolled hypertension
- •Subjects with any other conditions were considered unfit for this study determined by the investigator
研究组 & 干预措施
Utidelone
Experimental
Utidelone Injection: 35 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with recurrent or metastatic urothelial carcinoma Number of Cycles: until progression or unacceptable toxicity develops or up to 8 cycles.
干预措施: utidelone injection (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 24 months
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）
次要结局
- Clinical Benefit Rate(24 weeks)
- Adverse Events and Serious Adverse Events Safety(up to 3 years)
- Progression Free Survival (PFS)(24 months)
研究者
研究点 (1)
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