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

Last updated: February 4, 2019
Sponsor: VIFORFRANCE
Overall Status: Active - Recruiting

Phase

4

Condition

Vomiting

Cancer

Neoplasms

Treatment

N/A

Clinical Study ID

NCT03831633
PRAKYFRA-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 ofsolid malignant tumor

  • Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Careaccording to the summary of product characteristics based on the judgement of theirinvestigator's

  • Naïve of CT

  • ECOG performance up to 2

  • Able to read, understand and follow the study procedures

  • Patient with Health insurance

Exclusion

Exclusion Criteria:

  • Pregnancy and breastfeeding women;

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

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

Study Design

Total Participants: 426
Study Start date:
September 19, 2018
Estimated Completion Date:
July 31, 2019

Connect with a study center

  • CHU Avicenne

    Paris,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.