E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chemotherapy induced nausea and vomiting |
chemoterapií vyvolaná nevolnost a zvracení |
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E.1.1.1 | Medical condition in easily understood language |
prevention of chemotherapy induced nausea and vomiting |
prevence nevolnosti a zvracení vyvovalými chemoterapií |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056989 |
E.1.2 | Term | Nausea post chemotherapy |
E.1.2 | System Organ Class | 100000004856 |
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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 compare the single-dose fosaprepitant 150 mg regimen to the control regimen in terms of the proportion of patients with Complete Response (no vomiting and no use of rescue medication) from 25 to 120 hours (delayed phase) following initiation of moderately emetogenic chemotherapy (MEC). |
Zjistit poměr pacientů s dosaženou celkovou odpovědí (žádné zvracení bez užití záchranné medikace) u jednorázové dávky 150 mg fosaprepitantu v porovnání s kontrolní skupinou a to v rozmezí 25 až 120 hodin od zahájení středně emetogenní chemoterapie. |
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E.2.2 | Secondary objectives of the trial |
To compare the single-dose fosaprepitant 150 mg regimen and the control regimen in terms of the proportion of patients with a Complete Response (no vomiting and no use of rescue medication) in the overall phase (in the 120 hours following initiation of MEC). |
Zjistit poměr pacientů s dosaženou celkovou odpovědí (žádné zvracení bez užití záchranné medikace) u jednorázové dávky 150 mg fosaprepitantu v porovnání s kontrolní skupinou a to v celkovém rozmezí 120 hodin od zahájení středně emetogenní chemoterapie. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female ≥ 18 years
• Confirmed malignant disease
• Naïve to MEC and HEC
• Subject will receive a single IV dose of one or more MEC agents on Treatment Day 1. Combinations of an anthracycline and cyclophosphamide (AC MEC) are not premitted. |
• Muž nebo žena ve věku 18ti let a starší
• Potvrzené maligní onemocnění
• Dosud nepodána středně ani silně emetogenní chemoterapie
• U pacienta je plánováno podání jednorázové intravenózní dávky jedné
nebo více středně emetogenních chemoterapeutických látek v Den 1 (kromě kombinace antracyklinu a cyklofosfamidu) |
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E.4 | Principal exclusion criteria |
• Vomiting within 24 hours of treatment day 1
• Scheduled to receive AC,cisplatin, or other HEC agent
• Allergic to aprepitant, fosaprepitant, ondansetron or dexamethasone
• Taking systemic corticosteroids
• Known history of QT prolongation
• Patient has an active infection (e.g., pneumonia), any uncontrolled disease (e.g., diabetic ketoacidosis, congestive heart failure, bradyarrythmia’s, pre-existing gastrointestinal conditions/gastrointestinal obstruction) except for malignancy, or a history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study drug/comparator to the patient.
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• Zvracení v průběhu 24 hodin před Dnem 1
• Plánované podání AC, cisplatiny, nebo jiné silně emetogenní chemoterapie
• Alergie na aprepitant, fosaprepitant, ondansetron nebo dexametazon
• Užívání systémových kortikosteroidů
• Prodloužení intervalu QT v anamnéze
• Aktivní infekce (např. pneumonie), jakékoliv nekontrolovatelné onemocnění (např. diabetická ketoacidóza, kongestivní srdeční selhání, bradyarytmie, existující gastroinstestinální onemocnění/gastrointestinální obstrukce) kromě maligního onemocnění nebo jakéhokoliv jiného onemocnění, které dle názoru investigátora, může mást výsledky studie nebo představovat neodůvodněné riziko v podání hodnoceného léku/srovnávací látky pacientovi. .
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: The single-dose fosaprepitant 150 mg regimen provides superior control of CINV compared to the control regimen as measured by the proportion of patients with Complete Response in the delayed phase.
Safety: The single-dose fosaprepitant 150 mg regimen is well tolerated in patients receiving MEC.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0 to 120 hours following initiation of chemotherapy |
|
E.5.2 | Secondary end point(s) |
The single-dose fosaprepitant 150 mg regimen is superior to the control regimen with respect to the proportion of patients with a Complete Response in the overall phase (0in the 120 hours following initiation of MEC). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 to 120 hours following initiation of chemotherapy |
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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 | No |
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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 62 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Brazil |
Canada |
Chile |
Colombia |
India |
Mexico |
Peru |
Philippines |
Russian Federation |
South Africa |
Thailand |
Turkey |
Ukraine |
United States |
Venezuela, Bolivarian Republic of |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |