Overview

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

Status:
Not yet recruiting
Trial end date:
2023-07-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fujian Shengdi Pharmaceutical Co., Ltd.
Treatments:
Aprepitant
BB 1101
Dexamethasone
Dexamethasone acetate
Fosaprepitant
Palonosetron
Criteria
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