HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

A Randomized Phase III Study Evaluating the Efficacy and Safety of HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents

Study Overview

• Status: Completed
• Conditions: Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
• Intervention / Treatment: Drug: HR20013 + dexamethasone + palonosetron placebo; Drug: Palonosetron + dexamethasone + HR20013 placebo

• Study Type: Interventional
• Enrollment (Actual): 706
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center Yuexiu Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older, of either gender
2. Has a histologically or cytologically confirmed malignant disease
3. Naïve to cytotoxic chemotherapy
4. Scheduled to receive first course of moderate emetic risk anticancer agents
5. Predicted life expectancy of ≥ 3 months
6. Has a performance status (ECOG scale) of 0 to 1
7. Adequate organ function
8. female subjects of childbearing potential must have a negative blood pregnancy test within 72 hours before randomization; and must be non-lactating;
9. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Received or planned to receive total body irradiation, or radiation therapy to the abdomen, pelvis, Whole brain and spinal cord, head and neck , or chest within 7 days before randomization or within Days 1 to 8 of treatment
2. Scheduled to receive any moderate emetic risk anticancer agents from Day 1 to 6
3. Planned to receive treatment with a chemotherapy regimen including ordinary paclitaxel (with castor oil as solvent);
4. Medications with potential antiemetic efficacy within 2 days before randomization;
5. Began using opioids within 7 days prior to randomization or had a dose adjustment within the last 7 days.
6. Systemic corticosteroid therapy or sedative antihistamines within 7 days before randomization;
7. Use of palonosetron within 14 days before randomization;
8. Use of NK-1 receptor antagonists within 28 days before randomization;
9. Use of moderate to strong CYP3A4 inhibitors within 7 days before randomization; use of moderate to strong CYP3A4 inducers or specific CYP2D6 substrates within 28 days before randomization;
10. Vomiting and/or retching and nausea within 24 hours before randomization;
11. Subjects with symptomatic brain metastases, or with any symptoms suggestive of brain metastases or intracranial hypertension;
12. With uncontrolled serosal effusion;
13. Patients with serious cardiovascular diseases;
14. Concurrent uncontrolled hypertension before randomization;
15. Patients with active hepatitis B, active hepatitis C, acquired immunodeficiency syndrome (AIDS) or HIV test positive, and active syphilis test positive;
16. Concomitant diseases where dexamethasone is contraindicated;
17. The presence of severe or inadequately controlled diseases;
18. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
19. Participation in another clinical trial within 30 days prior to randomization (based on the use of study medication);
20. The presence of severe emotional or psychiatric disorders, as assessed by the investigator as unsuitable for participation in this study;
21. Subjects who, in the opinion of the investigator, have other conditions that make them inappropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR20013 + dexamethasone + palonosetron placebo	Drug: HR20013 + dexamethasone + palonosetron placebo; HR20013 + dexamethasone + palonosetron placebo
Active Comparator: Palonosetron + dexamethasone + HR20013 placebo	Drug: Palonosetron + dexamethasone + HR20013 placebo; Palonosetron + dexamethasone + HR20013 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate in the delayed phase	To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the delayed phase after initiation of moderate emetic risk anticancer agents.	24-120 hours after initiation of moderate emetic risk anticancer agents

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate in the overall phase.	To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the overall phase after initiation of moderate emetic risk anticancer agents.	0 - 120 hours after initiation of moderate emetic risk anticancer agents
Complete response rate in the acute phase.	To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the acute phase after initiation of moderate emetic risk anticancer agents.	0-24 hours after initiation of moderate emetic risk anticancer agents
Proportion of subjects with no significant nausea (maximum nausea on a visual analogue scale<25 mm)	To compare the proportion of subjects achieving no significant nausea (defined as maximum nausea on a visual analogue scale<25 mm) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively	the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no nausea (maximum nausea on a visual analogue scale<5 mm)	To compare the proportion of subjects achieving no nausea (defined as maximum nausea on a visual analogue scale<5 mm) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively	the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no emetic	To compare the proportion of subjects with no emetic event in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively	the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with no rescue medication	To compare the proportion of subjects with no rescue medication in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively	the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with complete protection	To compare the proportion of subjects achieving complete protection (defined as no emetic episode, no significant nausea and no need for rescue medication) in the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively	the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Proportion of subjects with total control	To compare the proportion of subjects achieving total control (defined as no emetic episode, no nausea and no need for rescue medication) in the acute phase (0-24 hours), the delayed phase (24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively	the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Time to treatment failure	Time to the first occurrence of emetic event or the first rescue medication	0-120 hours after initiation of moderate emetic risk anticancer agents
The score using the functional living index-emesis (FLIE) questionnaire	Changes in the score of FLIE before and after treatment	0-120 hours after initiation of moderate emetic risk anticancer agents
Adverse events	To analyse the rates of adverse events as assessed by CTCAE v5.0	Approximately 4 weeks

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): July 28, 2025
• Study Completion (Actual): October 3, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nausea; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Quinuclidines; Palonosetron; Dexamethasone
• Other Study ID Numbers: HR20013-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No