Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients

• Status: Unknown status
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VIFORFRANCE

Criteria

Inclusion Criteria:

• Male or female, Age ≥ 18 years

• Have a histological or cytological confirmed solid tumor malignancy

• Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor

• Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's

• Naïve of CT

• ECOG performance up to 2

• Able to read, understand and follow the study procedures

• Patient with Health insurance

Exclusion Criteria:

• Pregnancy and breastfeeding women;

• Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;

• Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision