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

Fujian Shengdi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Treatments: Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone; Drug: HR20013 for injection；dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05509634

HR20013-301

Details and patient eligibility

About

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

Enrollment: 754 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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754 participants in 2 patient groups

Treatment group A

Experimental group

Description:

HR20013 for injection + simulant of fosaprepitant dimeglumine for injection + simulant of palonosetron hydrochloride injection + dexamethasone

Treatment:

Drug: HR20013 for injection；dexamethasone

Treatment group B

Active Comparator group

Description:

simulant of HR20013 for injection + fosaprepitant dimeglumine for injection + palonosetron hydrochloride injection + dexamethasone + simulant of dexamethasone

Treatment:

Drug: fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone