NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving… (NCT06331520) | Clinical Trial Compass
CompletedPhase 3
NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens
China644 participantsStarted 2024-05-01
Plain-language summary
The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients ≥18 years old
✓. Patients who receive the high-emetic-risk anticancer agents.
✓. Patients who do not take a medicine, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, or research related agents, within 3 weeks prior to enrollment.
✓. No nausea or vomiting (grade II or above) within 72 hours before the start of chemotherapy.
✓. Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
✓. Subject has a life Expectation of at least 12 weeks.
✓. In accordance with the indication of chemotherapy and basic requirements： Peripheral haematology: Hb ≥9.0g/dL; absolute neutrophil count ≥1.5×109/L; Platelet count ≥80×109/L Blood biochemistry: Total bilirubin \< 1.25×ULN, ALT and AST ≤ 2.5×ULN; If liver metastasis, ALT and AST \< 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca) Other important organs function normally.
✓. Female patients of either non-childbearing potential or child-bearing potential use contraceptive methods throughout the clinical trial.
Exclusion criteria
✕. Patients receiving moderate or high emetic radioation therapy within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
✕. Within 24 hours after chemotherapy, patients receiving any known or potential antiemetic agents and appearing symptoms vomiting, nausea, or mild nausea symptoms.
What they're measuring
1
Percentage of patients with complete response (CR)
Timeframe: Within 0-120 hours from the initiation of chemotherapy