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This is a multicenter, randomized, double-blind, active-controlled dose-finding study. About 180 subjects who receive a high emetic chemotherapy are planned to be enrolled and randomized into three groups by a ratio of 1:1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542-A | Experimental |
| |
| HSK21542-B | Experimental |
| |
| Dolasetron | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Complete response | Acute Complete response was defined as no vomiting/retching and no rescue therapy over the first 24 hours after the initiation of high emetic chemotherapy regimen | 0 to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Complete response | Overall Complete response was defined as no vomiting/retching and no rescue therapy over the first 120 hours after the initiation of high emetic chemotherapy regimen | 0 to 120 hours |
| Delayed Complete response |
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Inclusion Criteria:
1.18 years of age or older, of either gender;
2. Has never been treated with chemotherapy regimen and plan to receive asingle day high emetic chemotherapy regimen by intravenous infusion,including but not limited to AC regimen, carboplatin AUC ≥ 4, Camustine>250 mg/m2, cisplatin, and other treatment options;
3. Diagnosed with a malignant solid tumor by histology or cytology;
4. Has an ECOG Performance Status of 0 or 1;
5. Predicted life expectancy of ≥3 months;
6. Adequate bone marrow, kidney, and liver function:
Absolute neutrophil count ≥ 1.5 × 109/L, white blood cell count ≥ 3.0 × 109/L;
Platelet count ≥ 75 × 109/L;
Hemoglobin ≥ 70 g/L;
Aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);
Alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);
Serum total bilirubin ≤ 2 × ULN (≤ 3 × ULN for patients with hepatocellular carcinoma or liver metastasis);
Creatinine ≤ 2 × ULN;
7. Subjects who agree to participate in the trial and voluntarily sign the Informed Consent Form (ICF);
Exclusion Criteria:
History or evidence of any of the following diseases prior to screening:
Allergies or contraindications to the study drugs or other drugs specified in the protocol (including chemotherapy drugs, investigational drugs and mimetics, dorasetron, aripipitan, dexamethasone, etc.) ;
Subjects who have experienced nausea, retching, or vomiting before 24 hours of randomization;
Subjects who have received abdominal or pelvic radiation therapy within the first 7 days of randomization or plan to receive abdominal or pelvic radiation therapy during the study period;
Subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming >2 units of alcohol on average daily (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol or 150 mL of wine);
Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 1 month prior to screening;
Female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion;
Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shen Xian | Contact | 13968888872 | 13968888872@163.com |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C060344 | dolasetron |
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| HSK21542 | Drug |
|
|
| Dolasetron | Drug |
|
|
Delayed Complete response was defined as no vomiting/retching and no rescue therapy over the 24 to 120 hours after the initiation of high emetic chemotherapy regimen
| 24 to 120 hours |