E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prevention of nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy |
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E.1.1.1 | Medical condition in easily understood language |
prevention of nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054133 |
E.1.2 | Term | Prophylaxis of nausea and vomiting |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
- 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal exclusion criteria |
• Pregnancy; • Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 6 of first chemotherapy cycle |
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E.5.2 | 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)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 6 of first chemotherapy cycle |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |