Clinical trial · Interventional
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
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.
NCT03831633CI-TRIAL-00036960unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Akynzeo | Drug | — | UNRESOLVED |
| Standard of Care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AKYNZEO
- interventionNames
- Drug: Akynzeo
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- interventionNames
- Drug: Standard of Care
Primary outcomes (1)
- measure
- Anti-emetic response
- timeFrame
- 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.