Oncology
Conditions
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
Interventions
DRUGAkynzeo
1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron). \- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4
DRUGStandard of Care
* oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3) * IV ondansetron 8 mg on Day 1 * Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4
Sponsors
VIFORFRANCE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactStéphane OUARY
Outcome results
None listed