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

Fujian Shengdi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

Treatments: Drug: HR20013 + dexamethasone + palonosetron placebo; Drug: Palonosetron + dexamethasone + HR20013 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06554184

HR20013-302

Details and patient eligibility

About

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

Enrollment: 706 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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706 participants in 2 patient groups

HR20013 + dexamethasone + palonosetron placebo

Experimental group

Treatment:

Drug: HR20013 + dexamethasone + palonosetron placebo

Palonosetron + dexamethasone + HR20013 placebo

Active Comparator group

Treatment:

Drug: Palonosetron + dexamethasone + HR20013 placebo