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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR20013 for injection+dexamethasone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR20013 for injectionï¼›dexamethason | Drug | HR20013 for injectionï¼›Drug for preventing nausea and vomiting caused by chemotherapy. dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t :area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration | 0 to 504 hours | |
| AUC0-∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity | 0 to 504 hours | |
| Cmax:observed maximum plasma concentration | 0 to 504 hours | |
| Tmax:observed time to reach Cmax | 0 to 504 hours | |
| T1/2z:apparent terminal half-life | 0 to 504 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 to 504 hours |
| Complete response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40866861 | Derived | 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. |
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HR20013 for injection combined with dexamethasone
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| 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) | 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) | During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours |
| No emetic | During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours |
| No rescue medication | During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours |
| Time to treatment failure | During 0-168 hours |