Clinical trial NCT05465681: Study of HR20013 for Injection in Patients With Malignant Solid Tumors
Official title: A Phase I Clinical Study of Safety and Pharmacokinetics of Single-dose HR20013 for Injection Combined With Dexamethasone in Patients With Malignant Solid Tumors Receiving Cisplatin-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HR20013 for injection combined with dexamethasone
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and pharmacokinetics of single-dose HR20013 for injection combined with dexamethasone in patients with malignant solid tumors receiving cisplatin-based chemotherapy.


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 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:

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 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

Primary outcomes:
measure: AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
timeFrame: 0 to 504 hours
measure: AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
timeFrame: 0 to 504 hours
measure: Cmax：observed maximum plasma concentration
timeFrame: 0 to 504 hours
measure: Tmax：observed time to reach Cmax
timeFrame: 0 to 504 hours
measure: T1/2z：apparent terminal half-life
timeFrame: 0 to 504 hours
Secondary outcomes:
measure: The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 0 to 504 hours
measure: Complete response
timeFrame: During the Acute Phase [0-24 hours after the start of cisplatin administration], the Delayed (>24-120 hours) phase, the overall (0-120 hours) phase, >120-168 hours and 0-168 hours
measure: No significant nausea (maximum nausea on a visual analogue scale<25 mm)
timeFrame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
measure: No nausea (maximum nausea on a visual analogue scale<5 mm)
timeFrame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
measure: No emetic
timeFrame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
measure: No rescue medication
timeFrame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
measure: Time to treatment failure
timeFrame: During 0-168 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: