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

Vifor

Status and phase: Unknown; Phase 4

Conditions: Oncology

Treatments: Drug: Akynzeo; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03831633

PRAKYFRA-01

Details and patient eligibility

About

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

Enrollment: 426 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

AKYNZEO

Experimental group

Treatment:

Drug: Akynzeo

Standard of Care

Active Comparator group

Treatment:

Drug: Standard of Care