Chemotherapy-Induced Nausea and Vomiting
Conditions
Brief summary
Compared With Fosaprepitant dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of QLM2010 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy.
Interventions
DRUGQLM2010 for injection；dexamethasone
QLM2010 for injection；Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
fosaprepitant dimeglumine for injection: Drug for preventing nausea and vomiting caused by chemotherapy palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to provide a written informed consent * 18 years of age or older, of either gender * Has a diagnosed malignant solid tumor through histological or cytological examination * Has never been treated with chemotherapy (Antitumor drugs are not used for cancer treatment, or intravesical instillation therapy for bladder cancer is not regarded as chemotherapy) * Receive the first course of cisplatin-based chemotherapy * Has a performance status (ECOG scale) of 0 to 2 * Predicted life expectancy of ≥ 3 months
Exclusion criteria
* .Subjects with poor blood pressure control after medication * Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension * Subjects with a history of severe cardiovascular diseases within 3 months prior to the administration of cisplatin, such as acute myocardial infarction, NYHA class II-IV heart failure, etc. * Subjects with a history of severe torsional ventricular tachycardia, QTcF\>480 ms * Subjects with mental disabilities or severe emotional or mental disorders, The investigators determined that inappropriate for participation in this clinical trial * Inadequate bone marrow, kidney, and liver function 10. Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 6 * Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 through Day 6 * Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before cisplatin-based chemotherapy * Participated in clinical trials of other drugs within 30 days prior to the administration of cisplatin (received experimental drugs) * Subjects receiving palonosetron hydrochloride within 21 days before cisplatin-based chemotherapy. Subjects who previously received NK-1 receptor antagonists within 28 days prior to cisplatin-based chemotherapy. Subjects receiving glucocorticoid within 7 days before cisplatin-based chemotherapy. * Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines, etc. * The investigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response during the overall phase after the start of the first cisplatin administration | [Time Frame: 0-120 hours after the start of the first cisplatin administration] | To compare the rate of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) after the start of the first cisplatin administration. |
Countries
China
Outcome results
None listed