NCT06593782尚未招募2 期
A Multicenter, Randomized, Double-blind, Active-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Acute Complete response
研究概览
简要总结
This is a multicenter, randomized, double-blind, active-controlled dose-finding study. About 180 subjects who receive a high emetic chemotherapy are planned to be enrolled and randomized into three groups by a ratio of 1:1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years of age or older, of either gender;
- •Has never been treated with chemotherapy regimen and plan to receive asingle day high emetic chemotherapy regimen by intravenous infusion，including but not limited to AC regimen, carboplatin AUC ≥ 4, Camustine>250 mg/m2, cisplatin, and other treatment options;
- •Diagnosed with a malignant solid tumor by histology or cytology;
- •Has an ECOG Performance Status of 0 or 1;
- •Predicted life expectancy of ≥3 months;
- •Adequate bone marrow, kidney, and liver function:
- •Absolute neutrophil count ≥ 1.5 × 109/L, white blood cell count ≥ 3.0 × 109/L;
- •Platelet count ≥ 75 × 109/L;
- •Hemoglobin ≥ 70 g/L;
- •Aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);
- •Alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);
- •Serum total bilirubin ≤ 2 × ULN (≤ 3 × ULN for patients with hepatocellular carcinoma or liver metastasis);
- •Creatinine ≤ 2 × ULN;
- •Subjects who agree to participate in the trial and voluntarily sign the Informed Consent Form (ICF);
排除标准
- •History or evidence of any of the following diseases prior to screening:
- •Suffering from primary or metastatic malignant tumors of the central nervous system;
- •Suffering from epilepsy, Parkinson's disease, or other central nervous system disorders that cause nausea and vomiting;
- •Suffering from intestinal obstruction or other digestive system diseases that may cause nausea and vomiting as determined by researchers;
- •Suffering from clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.);
- •History of obvious and chronic dizziness;
- •QT interval>450 ms during screening or taking concomitant medications due to prolonged QT interval or has risk factors for QT interval prolongation or correspon;
- •Allergies or contraindications to the study drugs or other drugs specified in the protocol (including chemotherapy drugs, investigational drugs and mimetics, dorasetron, aripipitan, dexamethasone, etc.) ;
- •Subjects who have experienced nausea, retching, or vomiting before 24 hours of randomization;
- •Subjects who have received abdominal or pelvic radiation therapy within the first 7 days of randomization or plan to receive abdominal or pelvic radiation therapy during the study period;
- •Subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming >2 units of alcohol on average daily (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol or 150 mL of wine);
- •Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 1 month prior to screening;
- •Female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion;
- •Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.
研究组 & 干预措施
HSK21542-A
Experimental
干预措施: HSK21542 (Drug)
HSK21542-B
Experimental
干预措施: HSK21542 (Drug)
Dolasetron
Active Comparator
干预措施: Dolasetron (Drug)
结局指标
主要结局
Acute Complete response
时间窗: 0 to 24 hours
Acute Complete response was defined as no vomiting/retching and no rescue therapy over the first 24 hours after the initiation of high emetic chemotherapy regimen
次要结局
- Overall Complete response(0 to 120 hours)
- Delayed Complete response(24 to 120 hours)
研究者
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