Study of HR20013 for Injection in Patients With Malignant Solid Tumors
NCT ID: NCT05465681
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2022-08-30
2023-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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HR20013 for injection+dexamethasone
HR20013 for injection；dexamethason
HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy.
dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Interventions
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HR20013 for injection；dexamethason
HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy.
dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Eligibility Criteria
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Inclusion Criteria
2. Has a diagnosed malignant tumor
3. has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2)
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
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 enrollment
5. Subjects who previously received NK-1 receptor antagonists within 14 days prior to enrollment
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 prior to the start of cisplatin
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
18 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Zhao Y, Ma Y, Yin T, Qin Z, Liu L, Kong G, Zhang R, Huang Y, Zhang L, Zhao H. Pharmacokinetics, safety, and efficacy of mixed formulation of fosrolapitant and palonosetron (HR20013) in combination with dexamethasone in patients with solid tumors scheduled for highly emetogenic cisplatin-based chemotherapy: a phase I trial. BMC Med. 2025 Aug 27;23(1):501. doi: 10.1186/s12916-025-04314-5.
Other Identifiers
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HR20013-102
Identifier Type: -
Identifier Source: org_study_id
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