Akynzeo as antiemetic treatment in patients with endometrial cancer treated with taxane - platinum combination chemotherapy. NOEME study.

Conditions

Endometrial cancer

Brief summary

Proportion of patients achieving complete response (CR: no emesis, no rescue medication) during the overall phase (0-120h) at cycle 1.

Detailed description

Proportion of patients achieving a complete response and complete control during the acute (0–24 h), delayed phase (>24 to 120 h) and overall (0-120h) phases of each cycle after the start of chemotherapy., Proportion of patients achieving no rescue medication, no emesis and no significant nausea (VAS score of <25 mm) during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle., Proportion of patients achieving CR and complete control during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with 10 CINV Risk Assessment tool in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy., The safety and tolerability of study drug (NEPA) will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory results by means of the occurrence, nature and severity of AEs.

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Interventions

DRUGOgivri 420 mg powder for concentrate for solution for infusion

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGAkynzeo 300 mg/0.5 mg hard capsules

DRUGDecadron “4 mg/1 ml Soluzione iniettabile”

DRUGJEMPERLI 500 mg concentrate for solution for infusion

DRUGPaclitaxel Kabi 6 mg/ml concentrato per soluzione per infusione

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGCARBOPLATINO Pfizer 10 mg/ml soluzione per infusione

DRUGOgivri 150 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving complete response (CR: no emesis, no rescue medication) during the overall phase (0-120h) at cycle 1.	—

Secondary

Measure	Time frame
Proportion of patients achieving a complete response and complete control during the acute (0–24 h), delayed phase (>24 to 120 h) and overall (0-120h) phases of each cycle after the start of chemotherapy., Proportion of patients achieving no rescue medication, no emesis and no significant nausea (VAS score of <25 mm) during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle., Proportion of patients achieving CR and complete control during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with 10 CINV Risk Assessment tool in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy., The safety and tolerability of study drug (NEPA) will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory	—

Measure

Time frame

Proportion of patients achieving a complete response and complete control during the acute (0–24 h), delayed phase (>24 to 120 h) and overall (0-120h) phases of each cycle after the start of chemotherapy., Proportion of patients achieving no rescue medication, no emesis and no significant nausea (VAS score of <25 mm) during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) after the start of chemotherapy of each cycle., Proportion of patients achieving CR and complete control during the acute (0-24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) phases after the start of each cycle according to Patient Emetogenicity Risk Profile assessed with 10 CINV Risk Assessment tool in patients with endometrial cancer receiving paclitaxel and carboplatin regimen with or without immunotherapy., The safety and tolerability of study drug (NEPA) will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory

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Countries

Italy

Outcome results

None listed