E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cancer; including Breast, Ovarian, Colorectal, Metastatic colorectal (those investigated as part of previous trials using Enadenotucirev). |
Cáncer; Incluyendo cáncer de mama, ovárico, colorrectal, colorectal metastásico (los investigados como parte de ensayos previos utilizando Enadenotucirev). |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 follow up subjects that have received enadenotucirev during a clinical trial to assess their long term well-being |
Realizar un seguimiento de participantes que han recibido enadenotucirev en el marco de un ensayo clínico para evaluar su bienestar a largo plazo |
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E.2.2 | Secondary objectives of the trial |
To collect all cancer treatments received after discontinuing treatment with enadenotucirev. |
Recopilar información sobre todos los tratamientos contra el cáncer recibidos tras interrumpir el tratamiento con enadenotucirev |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
l. Have participated in a clinical trial during which they received enadenotucirev, irrespective of the route of administration, dose received or tumour type being treated. 2. Able and willing to provide signed and dated written informed consent. 3. Able to comply with study procedures in the Investigator's opinión. |
1. Han participado en un ensayo clínico en cuyo marco recibieron enadenotucirev, con independencia de la vía de administración, la dosis recibida o el tipo de tumor tratado. 2. Capaces de aportar un escrito de consentimiento informado firmado y fechado, y con la voluntad de hacerlo. 3. Capaces, según el criterio del Investigador, de cumplir los procedimientos del estudio. |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to death |
Tiempo hasta la muerte |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Visits or telephone contacts will take place at intervals no greater than every 3 months to assess subject well-being and record cancer treatments received. |
Las visitas o contactos telefónicos tendrán lugar a intervalos no mayores de cada 3 meses para evaluar el bienestar del sujeto y registrar los tratamientos de cáncer que ha recibido. |
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E.5.2 | Secondary end point(s) |
Not applicable. |
No aplicable |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
No aplicable |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Assess subject well-being and record cancer treatments received. |
Evaluar el bienestar del sujeto y registrar los tratamientos contra el cáncer que ha recibido. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Estudio no intervencionista |
Non-interventional study |
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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.8.3 |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Belgium |
Spain |
United Kingdom |
United States |
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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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Subject participation will be until the end of the study, death, lost to follow up or withdrawal occurs. |
La participación del sujeto será hasta el final del estudio, la muerte, pérdida de seguimiento o retirada del estudio. |
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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 | 10 |
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 | 10 |
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 |