CTIS2023-504150-35-00
Recruiting
Phase 1
Akynzeo as antiemetic treatment in patients with endometrial cancer treated with taxane - platinum combination chemotherapy. NOEME study.
Fondazione IRCCS Istituto Nazionale Dei Tumori0 sites84 target enrollmentStarted: July 19, 2023Last updated:
ConditionsEndometrial cancerMedDRA version: 21.1Level: LLTClassification code: 10008448Term: Chemotherapy induced emesis prophylaxis Class: 10042613MedDRA version: 21.1Level: LLTClassification code: 10008449Term: Chemotherapy inducted emesis prophylaxis Class: 10042613Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 84
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 to 65+ (—)
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.
Investigators
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