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

Inclusion criteria

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

Exclusion criteria

• 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
• Scheduled to receive any moderate emetic risk anticancer agents from Day 1 to 6
• Planned to receive treatment with a chemotherapy regimen including ordinary paclitaxel (with castor oil as solvent);
• Medications with potential antiemetic efficacy within 2 days before randomization;
• Began using opioids within 7 days prior to randomization or had a dose adjustment within the last 7 days.
• Systemic corticosteroid therapy or sedative antihistamines within 7 days before randomization;
• Use of palonosetron within 14 days before randomization;
• Use of NK-1 receptor antagonists within 28 days before randomization;
• 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;
• Vomiting and/or retching and nausea within 24 hours before randomization;
• Subjects with symptomatic brain metastases, or with any symptoms suggestive of brain metastases or intracranial hypertension;
• With uncontrolled serosal effusion;
• Patients with serious cardiovascular diseases;
• Concurrent uncontrolled hypertension before randomization;
• Patients with active hepatitis B, active hepatitis C, acquired immunodeficiency syndrome (AIDS) or HIV test positive, and active syphilis test positive;
• Concomitant diseases where dexamethasone is contraindicated;
• The presence of severe or inadequately controlled diseases;
• Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
• Participation in another clinical trial within 30 days prior to randomization (based on the use of study medication);
• The presence of severe emotional or psychiatric disorders, as assessed by the investigator as unsuitable for participation in this study;
• Subjects who, in the opinion of the investigator, have other conditions that make them inappropriate for participation in this study.