HR20013 for treating nausea and vomiting in cancer patients

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 testing if a new drug called HR20013 can help cancer patients better manage nausea and vomiting from their first chemotherapy treatment compared to a standard medication.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06554184 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of HR20013 compared to palonosetron in managing nausea and vomiting associated with moderate emetic risk anticancer agents. Participants will receive either HR20013 with dexamethasone and a placebo for palonosetron, or palonosetron with dexamethasone and a placebo for HR20013. The study aims to determine which treatment is more effective for patients undergoing their first course of chemotherapy. It involves patients aged 18 and older with confirmed malignant diseases who are naïve to cytotoxic chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed malignant diseases who are about to start their first course of moderate emetic risk chemotherapy.

Not a fit: Patients who have previously received chemotherapy or those scheduled for certain radiation therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of nausea and vomiting for cancer patients undergoing chemotherapy.

How similar studies have performed: Other studies have shown promising results with similar antiemetic approaches, indicating potential for success in this area.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center Yuexiu Campus — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Yujiao Wang

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