E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Castration-Resistant Prostate Cancer (PCR) |
Cáncer de próstata metastásico resistente a la castración (CPRC) |
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E.1.1.1 | Medical condition in easily understood language |
Metastatic Castration-Resistant Prostate Cancer (PCR) |
Cáncer de próstata metastásico resistente a la castración (CPRC) |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
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 provide continued abiraterone acetate access for subjects in completed abiraterone acetate studies,who have received at least 3 months of abiraterone acetate treatment and who, based on investigator assessment, may benefit from continued access to abiraterone acetate. |
Proporcionar acceso continuado a acetato de abiraterona a sujetos que hayan participado en estudios ya finalizados con acetato de abiraterona en los que hayan recibido al menos 3 meses de tratamiento con dicho fármaco y que, según la evaluación del investigador, puedan beneficiarse de continuar con este tratamiento. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets. |
Sujetos que hayan participado en estudios ya finalizados con acetato de abiraterona en los que hayan recibido al menos 3 meses de tratamiento con dicho fármaco. |
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E.4 | Principal exclusion criteria |
- Medical conditions that require hospitalization.
- Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study. |
- Condición médica que requiera hospitalización.
- Cualquier condición o situación que en opinión del investigador pueda poner al paciente en un riesgo significativo, pueda confundir los resultados del estudio o pueda interferir significativamente la participación del paciente en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
No efficacy data will be collected and analyzed by the sponsor for this study. The sponsor will only collect serious adverse event data. No other safety data will be collected and analyzed by the sponsor. |
El promotor no recogerá ni analizará datos de eficacia para este ensayo. El promotor solo recogerá datos sobre eventos adversos graves. Ningún otro dato de seguridad será recogido y analizado por el promotor. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
No formal statistical analyses are planned. |
No se prevee realizar un analisis etadistico formal. |
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E.5.2 | Secondary end point(s) |
There are no secondary endpoints stablished. |
No se establecen objetivos secundarios. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Given that no secondary endpoints have been stablished, no timepoints are defined. |
Debido a que no se han establecido objetivos secundarios, no se ha definido calendario. |
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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 | Yes |
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) | Yes |
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 | 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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 |
Australia |
Austria |
Belgium |
Hungary |
Italy |
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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Last Vist of Last Subject |
Última visita del último paciente |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | 1 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 1 |