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

Phase 2

Not yet recruiting

• Conditions: Nausea and Vomiting, Chemotherapy-Induced
• Interventions: Drug: HSK21542; Drug: Dolasetron

• Registration Number: NCT06593782
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

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 groups by a ratio of 1:1:1.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-13
• Study Start: 2024-09-16
• Last Update Submitted: 2024-09-17
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-06-11
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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:

7. Absolute neutrophil count ≥ 1.5 × 109/L, white blood cell count ≥ 3.0 × 109/L;

8. Platelet count ≥ 75 × 109/L;

9. Hemoglobin ≥ 70 g/L;

10. Aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);

11. Alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);

12. Serum total bilirubin ≤ 2 × ULN (≤ 3 × ULN for patients with hepatocellular carcinoma or liver metastasis);

13. Creatinine ≤ 2 × ULN;

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

Exclusion Criteria

1. History or evidence of any of the following diseases prior to screening:

   1. Suffering from primary or metastatic malignant tumors of the central nervous system;
   2. Suffering from epilepsy, Parkinson's disease, or other central nervous system disorders that cause nausea and vomiting;
   3. Suffering from intestinal obstruction or other digestive system diseases that may cause nausea and vomiting as determined by researchers;
   4. Suffering from clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.);
   5. History of obvious and chronic dizziness;
   6. 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;

2. 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.) ;

3. Subjects who have experienced nausea, retching, or vomiting before 24 hours of randomization;

4. 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;

5. 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);

6. Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 1 month prior to screening;

7. 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;

8. Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSK21542-A	HSK21542	-
HSK21542-B	HSK21542	-
Dolasetron	Dolasetron	-

Primary Outcome Measures

Name	Time	Method
Acute Complete response	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

Secondary Outcome Measures

Name	Time	Method
Overall Complete response	0 to 120 hours	Overall Complete response was defined as no vomiting/retching and no rescue therapy over the first 120 hours after the initiation of high emetic chemotherapy regimen
Delayed Complete response	24 to 120 hours	Delayed Complete response was defined as no vomiting/retching and no rescue therapy over the 24 to 120 hours after the initiation of high emetic chemotherapy regimen