NCT03831633
Unknown
Phase 4
A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.
VIFORFRANCE1 site in 1 country426 target enrollmentStarted: September 19, 2018Last updated:
Overview
- Phase
- Phase 4
- Sponsor
- VIFORFRANCE
- Enrollment
- 426
- Locations
- 1
- Primary Endpoint
- Anti-emetic response
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AKYNZEO
Experimental
Intervention: Akynzeo (Drug)
Standard of Care
Active Comparator
Intervention: Standard of Care (Drug)
Outcomes
Primary Outcomes
Anti-emetic response
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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