Evaluating the Efficacy and Safety of HSK21542 Injection in Chemotherapy-induced Nausea and Vomiting

Официальное название

A Multicenter, Randomized, Double-blind, Active-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)

Обзор

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.

Вмешательства

• Препарат HSK21542
  1. HSK21542 injection was administered day 1; 2. Placebo to match Dorasetron was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;
• Препарат HSK21542
  1. HSK21542 injection was administered day 1; 2. Placebo to match Dorasetron was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;
• Препарат Dolasetron
  1. Placebo to match HSK21542 injection was administered day 1; 2. Dorasetron injection was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;

Первичные конечные точки

• Acute Complete response [Срок оценки: 0 to 24 hours]

Вторичные конечные точки (2)

• Overall Complete response [Срок оценки: 0 to 120 hours]
• Delayed Complete response [Срок оценки: 24 to 120 hours]

Критерии участия

Критерии включения

1.18 years of age or older, of either gender;

2\. 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;

3\. Diagnosed with a malignant solid tumor by histology or cytology;

4\. Has an ECOG Performance Status of 0 or 1;

5\. Predicted life expectancy of ≥3 months;

6\. 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;

7\. Subjects who agree to participate in the trial and voluntarily sign the Informed Consent Form (ICF);

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06593782 · HSK21542-501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗