E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bone Metastases in Subjects with Advanced Breast Cancer and Bone Metastases in Men with Hormone-Refractory Prostate Cancer |
Metástasis óseas en pacientes con cáncer de mama avanzado y metástasis óseas en hombres con cáncer de próstata hormonorrefractario |
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E.1.1.1 | Medical condition in easily understood language |
Bone Metastases in Subjects with Advanced Breast Cancer and Bone Metastases in Men with Hormone-Refractory Prostate Cancer |
Metástasis óseas en pacientes con cáncer de mama avanzado y metástasis óseas en hombres con cáncer de próstata hormonorrefractario |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062904 |
E.1.2 | Term | Hormone-refractory prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027475 |
E.1.2 | Term | Metastatic breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005993 |
E.1.2 | Term | Bone metastases |
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 facilitate the access of denosumab for subjects with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
Safety Objective: To further assess the safety of denosumab for subjects who have participated in open label extensions of a denosumab advanced cancer phase 3 study. |
Facilitar el acceso a denosumab a los sujetos con cáncer avanzado que han participado en un estudio de denosumab de fase 3 hasta que denosumab sea aprobado y esté disponible comercialmente.
Objetivo de seguridad: evaluar en más profundidad la seguridad de denosumab en los sujetos que han participado en extensiones abiertas de un estudio de fase 3 de denosumab en cáncer avanzado. |
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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 |
- Subjects was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study.
- Subject or subject?s legally acceptable representative has provided informed consent. |
- Los sujetos estuvieron incluidos previamente en un estudio de fase 3 con denosumab y participaron en la parte de extensión abierta de dicho estudio.
- El sujeto o su representante legal autorizado ha proporcionado el consentimiento informado. |
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E.4 | Principal exclusion criteria |
- Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment.
- Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective method of contraception during treatment and for 7 months after the end of treatment.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject will not be available for protocol-required study visits or procedures, to the best of the subject and investigator?s knowledge.
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures. |
- Mujer en edad fértil y que planee quedarse embarazada en los 7 meses posteriores al fin del tratamiento.
- Mujer en edad fértil que no desea utilizar, con su pareja, 2 métodos anticonceptivos altamente eficaces durante el tratamiento y durante los 7 meses posteriores al fin del tratamiento.
- El sujeto presenta una sensibilidad conocida a alguno de los productos que se administrarán durante la dosificación.
- Según informan el sujeto y el investigador, el sujeto no estará disponible para las visitas o procedimientos del estudio requeridos por el protocolo.
- El sujeto presenta un trastorno de cualquier tipo que, según el criterio del investigador, puede comprometer su capacidad de proporcionar el consentimiento informado escrito y/o cumplir con los procedimientos del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Subject incidence of treatment-emergent adverse events and anti-denosumab antibodies. |
Incidencia en los sujetos de acontecimientos adversos derivados del tratamiento y de anticuerpos anti-denosumab. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study (i.e. the time when the last subject is assessed or receives an intervention for evaluation in the study). |
El fin del estudio (el momento en el que el último sujeto se evalúa o recibe una intervención para la evaluación en el estudio). |
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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) | 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.8.3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 |
European Union |
Argentina |
Australia |
Brazil |
Chile |
India |
Israel |
Japan |
Mexico |
New Zealand |
Panama |
Peru |
Russian Federation |
South Africa |
Switzerland |
Ukraine |
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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
|
The end of the clinical study is defined as the time when the last subject is assessed or receives an intervention for evaluation in the study. |
El fin del estudio clínico se define como el momento en el que el último sujeto se evalúa o recibe una intervención para la evaluación en el 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 | 1 |
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 | 1 |
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 |