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

NCT ID: NCT06593782

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2025-09-01

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.

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

HSK21542-A

Group Type: EXPERIMENTAL

HSK21542

Intervention Type: DRUG

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;

HSK21542-B

Group Type: EXPERIMENTAL

HSK21542

Intervention Type: DRUG

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;

Dolasetron

Group Type: ACTIVE_COMPARATOR

Dolasetron

Intervention Type: DRUG

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;

Interventions

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;

Intervention Type: DRUG

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;

Intervention Type: DRUG

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;

Intervention Type: DRUG

Eligibility Criteria

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:

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

2. Platelet count ≥ 75 × 109/L;

3. Hemoglobin ≥ 70 g/L;

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

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

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

7. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Shen Xian

Role: CONTACT

13968888872@163.com

13968888872

Other Identifiers

HSK21542-501

Identifier Type: -

Identifier Source: org_study_id