E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer patients with bone metastasis |
Pacientes con cáncer de próstata resistente a la castración (hormonorresistente) con metástasis ósea |
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E.1.1.1 | Medical condition in easily understood language |
Prostate cancer which has spread to the bone |
Cáncer de próstata con diseminación ósea |
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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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036916 |
E.1.2 | Term | Prostate cancer stage D |
E.1.2 | System Organ Class | 100000004864 |
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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 define the long-term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia or hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice. |
Los objetivos principales son definir el perfil de seguridad a largo plazo del dicloruro de radio 223 (durante un máximo de 7 años después de la última dosis de dicloruro de radio 223); evaluar la incidencia de la leucemia, síndrome mielodisplásico, anemia aplásica y cáncer óseo primario o cualquier otra neoplasia maligna primaria nueva y, en pacientes que reciban quimioterapia citotóxica, evaluar la incidencia de neutrocitopenia febril o hemorragia durante el tratamiento con quimioterapia y hasta 6 meses después, con la frecuencia que indique la práctica clínica local. |
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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 |
1. Subject was previously enrolled in a selected company-sponsored feeder trial, and has received at least 1 dose of radium-223 dichloride or placebo in the feeder trial. 2. Written informed consent. |
1. El paciente estuvo inscrito previamente en un estudio preliminar patrocinado-por una empresa seleccionada y ha recibido al menos una dosis de dicloruro de radio 223 o placebo en el estudio preliminar. 2. Consentimiento informado por escrito. |
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E.4 | Principal exclusion criteria |
Not applicable for this study |
No hay criterios de exclusión en este estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Incidence of and severity of radium-223 dichloride/placebo related AEs -Incidence of radium-223 dichloride/placebo related SAEs -Incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy -In subjects who receive cytotoxic chemotherapy: incidence of febrile neutropenia or hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice |
- Todos los acontecimientos adversos (AA) y los acontecimientos adversos graves (AAG) relacionados con el dicloruro de radio 223/placebo. - Todas las apariciones de leucemia, síndrome mielodisplásico, anemia aplásica y cáncer óseo primario o cualquier otra neoplasia maligna primaria nueva. - Tratamiento antineoplástico (incluida cualquier quimioterapia citotóxica sistémica o radioterapia para tumores malignos; inhibidores de la síntesis de andrógenos/antagonistas del receptor de andrógenos y radioterapia; excluidos los analgésicos). - En pacientes que reciban quimioterapia citotóxica: todas las apariciones de neutrocitopenia febril o hemorragia durante su tratamiento conquimioterapia y hasta los 6 meses posteriores. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every 6 months |
Cada 6 meses |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 101 |
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 |
Brazil |
Canada |
Chile |
Czech Republic |
Finland |
Germany |
Israel |
Italy |
Japan |
Korea, Democratic People's Republic of |
Netherlands |
Norway |
Poland |
Russian Federation |
Singapore |
Spain |
Sweden |
Taiwan |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 10 |