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

NCT06593782 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK21542-501
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Acute Complete response

  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

  0 to 24 hours

Secondary Outcomes (2)

• Overall Complete response

  0 to 120 hours

• Delayed Complete response

  24 to 120 hours

Study Arms (3)

HSK21542-A

EXPERIMENTAL

Drug: HSK21542

HSK21542-B

EXPERIMENTAL

Drug: HSK21542

Dolasetron

ACTIVE COMPARATOR

Drug: Dolasetron

Interventions

HSK21542 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-A

Dolasetron 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;

Dolasetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

dolasetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shen Xian

CONTACT

13968888872; 13968888872@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion: June 11, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09