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HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents | Clinical Trials | Clareo Health

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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

NCT06554184•Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 more criteria

Locations (1)

Sun Yat-sen University Cancer Center Yuexiu Campus

Guangzhou, Guangdong, China

Key Dates

Start Date

September 3, 2024

Primary Completion Date

July 28, 2025

Completion Date

October 3, 2025

Last Updated

November 17, 2025

Enrollment

706

ACTUAL participants

Conditions

Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

Interventions

HR20013 + dexamethasone + palonosetron placebo

DRUG

Palonosetron + dexamethasone + HR20013 placebo

DRUG