Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors

Compared With Fosaprepitant Dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of HR20013 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.

Study Overview

• Status: Completed
• Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
• Intervention / Treatment: Drug: HR20013 for injection；dexamethasone; Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 754
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center Yuexiu Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older, of either gender
2. Has a diagnosed malignant tumor
3. has never been treated with chemotherapy and is to receive the first course of cisplatin-based chemotherapy
4. Predicted life expectancy of ≥ 3 months
5. Has a performance status (ECOG scale) of 0 to 1
6. Adequate bone marrow, kidney, and liver function
7. Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
8. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
2. Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
3. Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
4. Subjects receiving palonosetron hydrochloride within 14 days before randomization
5. Subjects who previously received NK-1 receptor antagonists within 28 days prior to randomization
6. Subjects with a history of myocardial infarction or unstable angina pectoris
7. Subjects with atrioventricular block or cardiac insufficiency
8. Subjects with poor blood pressure control after medication
9. Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
10. Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before randomization
11. Participated in clinical trials of other drugs (received experimental drugs)
12. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone	Drug: HR20013 for injection；dexamethasone; HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Active Comparator: Treatment group B; simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone	Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone; fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response during the overall phase after the start of the first cisplatin administration	To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration.	0-120 hours after the start of the first cisplatin administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response during the acute phase, the delayed phase, >120-168 hours, and 0-168 hours after the start of the first cisplatin administration	To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.	the acute phase (0-24 hours), the delayed phase (>24-120 hours), >120-168 hours, and 0-168 hours after the first cisplatin administration
Complete response during the acute phase, the delayed phase, the overall phase, >120-168 hours, and 0-168 hours after the start of the second cisplatin administration	To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.	the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours, and 0-168 hours after the start of the second cisplatin administration
No significant nausea	To compare the proportion of subjects with no significant nausea (defined as maximum nausea on a visual analogue scale <25 mm) during the specified period.	the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No nausea	To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale <5 mm) during the specified period.	the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No emetic	To compare the proportion of subjects with no emetic event during the specified period.	the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
No rescue medication	To compare the proportion of subjects who received no rescue medication during the specified period.	the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Complete protection	To compare the proportion of subjects with complete protection (defined as patients who experienced no emetic event and received no rescue medication and had no significant nausea) during the specified period).	the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Total control	To compare the proportion of subjects with total control (defined as patients who experienced no emetic events and received no rescue medication and had no nausea) during the specified period.	the acute phase (0-24 hours), the delayed phase (>24-120 hours), the overall phase (0-120 hours), >120-168 hours and 0-168 hours after the start of each cisplatin administration
Time to treatment failure	Time to the first occurrence of emetic event or the first rescue medication.	During 0-168 hours after the start of each cisplatin administration
The score using the functional living index-emesis (FLIE) questionnaire	To compare the change of score using FLIE questionnaire before and after treatment.	During 0-168 hours after the start of each cisplatin administration
Number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0	To compare the number of participants with injection site reaction and with treatment-related adverse events as assessed by CTCAE v5.0.	0 to 504 hours after the start of each cisplatin administration
plasma concentration of HR20013	To analyse the plasma concentration of HR20013 at the specified time points.	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

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): June 19, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Neurokinin-1 Receptor Antagonists; Dexamethasone; Dexamethasone acetate; BB 1101; Palonosetron; Aprepitant; Fosaprepitant
• Other Study ID Numbers: HR20013-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No