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Clinical Trials/2023-504150-35-00
2023-504150-35-00
Recruiting
Phase 4

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

Fondazione IRCCS Istituto Nazionale Dei Tumori8 sites in 1 country84 target enrollmentStarted: November 7, 2023Last updated:
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Overview

Phase
Phase 4
Status
Recruiting
Enrollment
84
Locations
8
Primary Endpoint
Proportion of patients achieving complete response (CR: no emesis, no rescue medication) during the overall phase (0-120h) at cycle 1.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate effectiveness of a single oral dose of NEPA in terms of complete response (CR: no emesis, no rescue medication) in the overall phase (0-120h) at cycle 1 in chemotherapy-naïve patients with endometrial cancer receiving paclitaxel and carboplatin with or without immunotherapy.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Sex
Female
Accepts Healthy Volunteers
No

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
  • •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
  • •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.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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.

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Dr. Monika Ducceschi

Scientific

Fondazione IRCCS Istituto Nazionale Dei Tumori

Study Sites (8)

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