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

NCT ID: NCT05509634

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 754 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2023-08-30

Brief Summary

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

Conditions

Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A

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

Group Type: EXPERIMENTAL

HR20013 for injection；dexamethasone

Intervention Type: DRUG

HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy

dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

Treatment group B

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

Group Type: ACTIVE_COMPARATOR

fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center Yuexiu Campus

Guangzhou, Guangdong, China

Countries

China

References

Zhou H, Zhao Y, Zhang M, Yao J, Leng S, Li X, Lin L, Chen J, Zhang S, Qin X, Qin Z, Yi T, Wang R, Li X, Yu Y, Wang Z, Zheng Q, Mei J, Zang A, Li N, Cao F, Cao K, Li W, Lu Y, Lin D, Zhou Y, Yang R, Fang W, Zhou N, Yang Y, Zhang Y, Chen G, Zhou T, Yang X, Wang H, Wang Y, Huang Y, Zhang L. Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. J Clin Oncol. 2025 Mar 20;43(9):1123-1136. doi: 10.1200/JCO-24-01308. Epub 2024 Dec 2.

Reference Type: DERIVED

PMID: 39621965 (View on PubMed)

Other Identifiers

HR20013-301

Identifier Type: -

Identifier Source: org_study_id