Status:
NOT_YET_RECRUITING
Evaluating the Efficacy and Safety of HSK21542 Injection in Chemotherapy-induced Nausea and Vomiting
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Nausea and Vomiting, Chemotherapy-Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 gr...
Eligibility Criteria
Inclusion
- 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);
Exclusion
- 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.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06593782
Start Date
September 16 2024
End Date
September 1 2025
Last Update
September 19 2024
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