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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002293-44-FR

Enrollment

426

Registered

2018-06-13

Start date

2018-07-25

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prevention of nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy MedDRA version: 20.1 Level: PT Classification code 10054133 Term: Prophylaxis of nausea and vomiting System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: AKYNZEO® Pharmaceutical Form: Capsule, soft INN or Proposed INN: AKYNZEO CAS Number: 290297-26-6 Current Sponsor code: AKYNZEO Other descriptive name: NETUPITANT Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the non-inferiority in terms of effectiveness of AKYNZEO® compared to SoC for the prevention of CINV in patients receiving a MEC chemotherapy regimen in the overall phase.;Secondary Objective: - Evaluate the effectiveness of AKYNZEO® compared to SoC in both acute and delayed phases - Evaluate the effectiveness of AKYNZEO® compared to SoC in both subgroups (MEC/AC and MEC/non-AC) - Evaluate the effectiveness of AKYNZEO® compared to SoC on the severity of nausea - Evaluate the Quality of Life in patients receiving AKYNZEO® or SoC for the prevention of CINV - Describe the safety profile of AKYNZEO® compared to SoC ;Primary end point(s): Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC / MEC-non AC / MEC AC. In order to preserve type-I error rate, a gatekeeping procedure will be followed, starting with whole MEC population. If non-inferiority is demonstrated among MEC population, MEC-AC will be tested. If non-inferiority is achieved for MEC/AC, MEC/non-AC will be tested. At each step, if non-inferiority is not demonstrated, the sequence stops.;Timepoint(s) of evaluation of this end point: Day 6 of first chemotherapy cycle	—

Measure

Time frame

Main Objective: To demonstrate the non-inferiority in terms of effectiveness of AKYNZEO® compared to SoC for the prevention of CINV in patients receiving a MEC chemotherapy regimen in the overall phase.;Secondary Objective: - Evaluate the effectiveness of AKYNZEO® compared to SoC in both acute and delayed phases - Evaluate the effectiveness of AKYNZEO® compared to SoC in both subgroups (MEC/AC and MEC/non-AC) - Evaluate the effectiveness of AKYNZEO® compared to SoC on the severity of nausea - Evaluate the Quality of Life in patients receiving AKYNZEO® or SoC for the prevention of CINV - Describe the safety profile of AKYNZEO® compared to SoC ;Primary end point(s): Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC / MEC-non AC / MEC AC. In order to preserve type-I error rate, a gatekeeping procedure will be followed, starting with whole MEC population. If non-inferiority is demonstrated among MEC population, MEC-AC will be tested. If non-inferiority is achieved for MEC/AC, MEC/non-AC will be tested. At each step, if non-inferiority is not demonstrated, the sequence stops.;Timepoint(s) of evaluation of this end point: Day 6 of first chemotherapy cycle

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Secondary

Measure	Time frame
Secondary end point(s): - CR in acute and delayed phase - CR in acute, delayed and overall phase, in subgroups populations - Severity of nausea will be assessed using VAS scale - Quality of Life will be assessed with EQ-5D and FLIE - Safety parameters will comprise the recording and assessing all AE /serious adverse events (SAEs) ;Timepoint(s) of evaluation of this end point: Day 6 of first chemotherapy cycle	—

Measure

Time frame

Secondary end point(s): - CR in acute and delayed phase - CR in acute, delayed and overall phase, in subgroups populations - Severity of nausea will be assessed using VAS scale - Quality of Life will be assessed with EQ-5D and FLIE - Safety parameters will comprise the recording and assessing all AE /serious adverse events (SAEs) ;Timepoint(s) of evaluation of this end point: Day 6 of first chemotherapy cycle

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Countries

France

Contacts

Public ContactCLINICAL OPERATION MANAGER

CAPIONIS

stephane.ouary@capionis.com33662755802

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026