Clinical trial NCT06554184: HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
Official title: A Randomized Phase III Study Evaluating the Efficacy and Safety of HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: Complete response rate in the delayed phase
timeFrame: 24-120 hours after initiation of moderate emetic risk anticancer agents
Secondary outcomes:
measure: Complete response rate in the overall phase.
timeFrame: 0 - 120 hours after initiation of moderate emetic risk anticancer agents
measure: Complete response rate in the acute phase.
timeFrame: 0-24 hours after initiation of moderate emetic risk anticancer agents
measure: Proportion of subjects with no significant nausea (maximum nausea on a visual analogue scale<25 mm)
timeFrame: 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
measure: Proportion of subjects with no nausea (maximum nausea on a visual analogue scale<5 mm)
timeFrame: 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
measure: Proportion of subjects with no emetic
timeFrame: 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
measure: Proportion of subjects with no rescue medication
timeFrame: 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
measure: Proportion of subjects with complete protection
timeFrame: 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
measure: Proportion of subjects with total control
timeFrame: 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
measure: Time to treatment failure
timeFrame: 0-120 hours after initiation of moderate emetic risk anticancer agents
measure: The score using the functional living index-emesis (FLIE) questionnaire
timeFrame: 0-120 hours after initiation of moderate emetic risk anticancer agents
measure: Adverse events
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center Yuexiu Campus
state: Guangdong
Study officials:
References: