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

Phase 1

Recruiting

Conditions: Endometrial cancer
MedDRA version: 21.1Level: LLTClassification code: 10008448Term: Chemotherapy induced emesis prophylaxis Class: 10042613
MedDRA version: 21.1Level: LLTClassification code: 10008449Term: Chemotherapy inducted emesis prophylaxis Class: 10042613
Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Registration Number: CTIS2023-504150-35-00

Lead Sponsor: Fondazione IRCCS Istituto Nazionale Dei Tumori

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent., Subject has histologically or cytologically proven endometrial cancer., Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2., Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician., Naive to chemotherapy.

Exclusion Criteria

Patients will experience emesis within the 24 hours before receipt of 1 course of chemotherapy., Patients will be scheduled to radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5., Patients will be scheduled to undergo bone marrow or stem-cell transplant., Chronic systemic corticosteroid use., Brain metastasis., Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder., History or predisposition to cardiac conduction abnormalities, torsade des pointes or severe cardiovascular diseases., Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment.