A randomized study to evaluate the effectiveness of Akynzeo® and Standard of care for the prevention of nausea and vomiting in cancer patients receiving chemotherapy

Phase 1

• Conditions: prevention of nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy; MedDRA version: 20.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2018-002293-44-FR
• Lead Sponsor: VIFOR FRANCE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-13
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

•Informed consent of the patient
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 426
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnancy;
•Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified