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Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors
Guangzhou, China
Phase 3
Waitlist Available
Research Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first hr20013 administration, and day 1 of the second hr20013 administration
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.
See full description
Eligible Conditions
- Prevention of Nausea and Vomiting
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first hr20013 administration, and day 1 of the second hr20013 administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluation time points include 1-2 hours, 5-10 hours, and 3 days after the start of the first hr20013 administration, and day 1 of the second hr20013 administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response during the overall phase after the start of the first cisplatin administration
Secondary study objectives
Complete protection
Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration
Cisplatin
+9 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment group AExperimental Treatment1 Intervention
HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone
Group II: Treatment group BActive Control1 Intervention
simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HR20013 for injection；dexamethasone
2022
Completed Phase 3
~760
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Who is running the clinical trial?
Fujian Shengdi Pharmaceutical Co., Ltd.Lead Sponsor
35 Previous Clinical Trials
5,307 Total Patients Enrolled