HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
NCT Number: NCT06554184
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
Interventions: DRUG: HR20013 + dexamethasone + palonosetron placebo|DRUG: Palonosetron + dexamethasone + HR20013 placebo
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-07

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

Primary Outcome Measures: Complete response rate in the delayed phase, To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the delayed phase after initiation of moderate emetic risk anticancer agents., 24-120 hours after initiation of moderate emetic risk anticancer agents
Secondary Outcome Measures: Complete response rate in the overall phase., To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the overall phase after initiation of moderate emetic risk anticancer agents., 0 - 120 hours after initiation of moderate emetic risk anticancer agents|Complete response rate in the acute phase., To compare the rate of subjects achieving complete response (defined as no emetic episode and no need for rescue medication) in the acute phase after initiation of moderate emetic risk anticancer agents., 0-24 hours after initiation of moderate emetic risk anticancer agents|Proportion of subjects with no significant nausea (maximum nausea on a visual analogue scale<25 mm), To compare the proportion of subjects achieving no significant nausea (defined as maximum nausea on a visual analogue scale\<25 mm) in 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, 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|Proportion of subjects with no nausea (maximum nausea on a visual analogue scale<5 mm), To compare the proportion of subjects achieving no nausea (defined as maximum nausea on a visual analogue scale\<5 mm) in 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, 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|Proportion of subjects with no emetic, To compare the proportion of subjects with no emetic event in 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, 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|Proportion of subjects with no rescue medication, To compare the proportion of subjects with no rescue medication in 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, 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|Proportion of subjects with complete protection, To compare the proportion of subjects achieving complete protection (defined as no emetic episode, no significant nausea and no need for rescue medication) in 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, 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|Proportion of subjects with total control, To compare the proportion of subjects achieving total control (defined as no emetic episode, no nausea and no need for rescue medication) in 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, 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|Time to treatment failure, Time to the first occurrence of emetic event or the first rescue medication, 0-120 hours after initiation of moderate emetic risk anticancer agents|The score using the functional living index-emesis (FLIE) questionnaire, Changes in the score of FLIE before and after treatment, 0-120 hours after initiation of moderate emetic risk anticancer agents|Adverse events, To analyse the rates of adverse events as assessed by CTCAE v5.0, Approximately 4 weeks