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

ConditionNausea and Vomiting, Chemotherapy-Induced
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    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

    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;

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: HSK21542-AExperimental treatment 1 intervention
Group B: HSK21542-BExperimental treatment 1 intervention
Group C: DolasetronActive comparator 1 intervention

Trial outcomes

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

Time frame
0 to 24 hours

Secondary outcomes

1

Overall Complete response

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

Time frame
0 to 120 hours
2

Delayed Complete response

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

Time frame
24 to 120 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: