E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Venous thromboembolism event associated with cancer |
Paziente con tromboembolia venosa e cancro |
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E.1.1.1 | Medical condition in easily understood language |
Venous thromboembolism event associated with cancer |
Paziente con tromboembolia venosa e cancro |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066899 |
E.1.2 | Term | Venous thromboembolism |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028997 |
E.1.2 | Term | Neoplasm malignant |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 evaluate the impact of edoxaban related adverse events on antineoplastic therapy, defined as antineoplastic therapy delays/interruption due to ADRrelated to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, ipersensitivity reactions). To evaluate the quality of life of patients treated with Edoxaban. Quality of life will be evaluated using validate quality of life questionnaires: FACT-G , PACT-Q2 and Acts. |
Valutare l’impatto degli eventi avversi correlati ad edoxaban sulla terapia antineoplastica in termini di interruzioni o ritardi del trattamento antineoplastico (sanguinamenti, tossicità epatobiliare, tossicità renale, anemia, reazioni di ipersensibilità). Valutare la qualità di vita dei pazienti trattati con edoxaban utilizzando I questionari FACT-G, PACT e Acts. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the compliance to Edoxaban treatment. For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose. A diary for record the tablet intake and missing dose will be provided to all patients. To evaluate the safety of edoxaban treatment. The adverse event severity grading scale for the National Cancer Institute Common Terminology for Adverse Events, Version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity. |
Valutare la compliance al trattamento con edoxaban, tramite il confronto tra la dose prescritta e quella realmente assunta dai pazienti. Valutare la sicurezza del trattamento con edoxaban. Gli eventi avversi verranno valutati in base al National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult subjects presenting with VTE associated with cancer. - Patient must be receiving sistemic antineoplastic therapy (such as chemotherapy, target therapy, immuntherapy, ormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy. |
- Pazienti con tromboembolia venosa durante trattamento antineoplastico (chemioterapia, target therapy, immunoterapia, ormonoterapia). - Pazienti che restino candidati a ricevere almeno altri 3 mesi di terapia antineoplastica dopo la diagnosi di evento tromboembolico. |
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E.4 | Principal exclusion criteria |
• Hypersensitivity to the active substance or to any of the excipients; • clinically significant active bleeding; • hepatic disease associated with coagulopathy and clinically relevant bleeding risk; • lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • uncontrolled severe hypertension; • concomitant treatment with any other anticoagulants; • pregnancy and breast-feeding. |
• Ipersensibilità nota verso edoxaban o i suoi eccipienti; • Sanguinamento significativamente attivo; • Patologie epatiche associate a coagulopatia e rischio di sanguinamento elevato; • Lesioni o condizioni che siano ad alto rischio di sanguinamento. Questo può includere ulcere gastrointestinali recenti o attive, presenza di neoplasia ad alto rischio di sanguinamento, recente danno cerebrale o spinale, recente chirurgia oftalmica, spinale o cerebrale, recente emorragia intracranica, presenza o sospetto di varici gastroesofagee, malformazioni arteriovenose, aneurisma vascolare o anormalità vascolari intraspinali o intracraniche maggiori; • Ipertensione severa e non controllata; • Trattamento concomitante con qualsiasi anticoagulante; • Gravidanza o allattamento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
A) To evaluate the impact of edoxaban related adverse events on antineoplastic therapy, defined as antineoplastic therapy delays/interruption due to ADRrelated to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, ipersensitivity reactions). B) To evaluate the quality of life of patients treated with Edoxaban. Quality of life will be evaluated using validate quality of life questionnaires: FACT-G , PACT-Q2 and Acts. |
A) Valutare l’impatto degli eventi avversi correlati ad edoxaban sulla terapia antineoplastica in termini di interruzioni o ritardi del trattamento antineoplastico (sanguinamenti, tossicità epatobiliare, tossicità renale, anemia, reazioni di ipersensibilità) B) Valutare la qualità di vita dei pazienti trattati con edoxaban utilizzando I questionari FACT-G, PACT e Acts. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0-1-3-6-12 month |
0-1-3-6-12 mesi |
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E.5.2 | Secondary end point(s) |
A) To evaluate the compliance to Edoxaban treatment. For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose. A diary for record the tablet intake and missing dose will be provided to all patients. B) To evaluate the safety of edoxaban treatment. The adverse event severity grading scale for the National Cancer Institute Common Terminology for Adverse Events, Version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity. |
A) Valutare la compliance al trattamento con edoxaban, tramite il confronto tra la dose prescritta e quella realmente assunta dai pazienti. B) Valutare la sicurezza del trattamento con edoxaban. Gli eventi avversi verranno valutati in base al National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0-1-3-6-12 month |
0-1-3-6-12 mesi |
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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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 30 |
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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |