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

Fujian Shengdi Pharmaceutical Co., Ltd.754 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

754

Conditions

Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Interventions

HR20013 for injection；dexamethasoneDRUG

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

fosaprepitant dimeglumine for injection；palonosetron hydrochloride injection；dexamethasoneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun Yat-sen University Cancer Center Yuexiu Campus

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: 0-120 hours after the start of the first cisplatin administration

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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