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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
24
HR20013 for injection;Drug for preventing nausea and vomiting caused by chemotherapy. dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
AUC0-t :area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Time frame: 0 to 504 hours
AUC0-∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
Time frame: 0 to 504 hours
Cmax:observed maximum plasma concentration
Time frame: 0 to 504 hours
Tmax:observed time to reach Cmax
Time frame: 0 to 504 hours
T1/2z:apparent terminal half-life
Time frame: 0 to 504 hours
The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0
The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 0 to 504 hours
Complete response
Time frame: 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
No significant nausea (maximum nausea on a visual analogue scale<25 mm)
Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
No nausea (maximum nausea on a visual analogue scale<5 mm)
Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
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No emetic
Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
No rescue medication
Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours
Time to treatment failure
Time frame: During 0-168 hours