Status:
UNKNOWN
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
Lead Sponsor:
VIFORFRANCE
Conditions:
Oncology
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 setti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2019
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT03831633
Start Date
September 19 2018
End Date
July 31 2019
Last Update
February 6 2019
Active Locations (1)
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1
CHU Avicenne
Paris, France