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

Phase 4

• Conditions: Oncology
• Interventions: Drug: Akynzeo; Drug: Standard of Care

• Registration Number: NCT03831633
• Lead Sponsor: VIFORFRANCE

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Status Verified: 2019-02
• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-04
• Last Update Submitted: 2019-02-04
• Study First Posted: 2019-02-06
• Last Update Posted: 2019-02-06
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 426

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKYNZEO	Akynzeo	-
Standard of Care	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
Anti-emetic response	1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.	Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen

Trial Locations

Locations (1)

CHU Avicenne; 🇫🇷 Paris, France