To Evaluate the Efficacy and Safety of QLM2010 for Prevention of Chemotherapy-induced Nausea and … (NCT07081256) | Clinical Trial Compass
CompletedPhase 3
To Evaluate the Efficacy and Safety of QLM2010 for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy.
China665 participantsStarted 2025-01-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Complete response during the overall phase after the start of the first cisplatin administration
Timeframe: [Time Frame: 0-120 hours after the start of the first cisplatin administration]