E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced ovarian, breast, or prostate cancer |
cancer avanzado de próstata, pecho u ovárico |
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E.1.1.1 | Medical condition in easily understood language |
advanced ovarian, breast, or prostate cancer |
cancer avanzado de próstata, pecho u ovárico |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033128 |
E.1.2 | Term | Ovarian 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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | 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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
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 long-term safety and tolerability of niraparib |
Evaluar la seguridad y tolerabilidad a largo plazo de niraparib |
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E.2.2 | Secondary objectives of the trial |
No secondary objectives will be evaluated in this study. |
No se evaluarán objetivos secundarios en este estudio. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject is able to understand the study procedures and agrees to participate in the study by providing written informed consent. 2. Subject is willing and able to comply with scheduled visits, treatment plans, and any other study procedures. 3. Subject is currently receiving treatment with niraparib (as monotherapy or in combination) in a GSK/TESARO-sponsored study that has fulfilled the requirements for the primary objective. 4. Subject is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements. 5. Subjects of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug. |
1. El sujeto puede comprender los procedimientos del estudio y aceptar participar en el mismo proporcionando un consentimiento informado por escrito. 2. El sujeto desea y puede cumplir con las visitas programadas, los planes de tratamiento y cualquier otro procedimiento del estudio. 3. El sujeto está recibiendo actualmente tratamiento con niraparib (en monoterapia o en combinación) en un estudio patrocinado por GSK/TESARO que ha cumplido con los requisitos fijados para el objetivo principal. 4. El sujeto se está beneficiando actualmente del tratamiento con niraparib evaluado por el investigador de acuerdo con los requisitos del protocolo del estudio principal. 5. Los sujetos en edad fértil que sean sexualmente activos y sus parejas deben aceptar el uso de un método anticonceptivo eficaz durante la administración del tratamiento del estudio y hasta 180 días después de recibir la última dosis del fármaco. |
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E.4 | Principal exclusion criteria |
1. Subject has been permanently discontinued from niraparib treatment in the parent study for any reason. 2. Subject currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Subjects meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume. 3. Subject is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Subject is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment). |
1. Al sujeto se le suspendió de forma permanente la administración del tratamiento con niraparib en el estudio principal por cualquier motivo. 2. El sujeto presenta actualmente las mismas toxicidades no resueltas por las que se interrumpió la administración de niraparib en el estudio principal. Los sujetos que cumplan con todos los demás criterios de elegibilidad pueden inscribirse una vez que se hayan resuelto las toxicidades y se permita reanudar el tratamiento con niraparib. 3. El sujeto es mujer y está embarazada o espera concebir hijos mientras se le administra el fármaco del estudio o en los 180 días después a la administración de la última dosis del fármaco. El sujeto es mujer y está amamantando o espera amamantar en los 30 días posteriores a la recepción de la dosis final del fármaco del estudio (las mujeres no deben amamantar ni almacenar leche materna para usarla mientras estén en tratamiento con niraparib y en los 30 días posteriores a la administración de la dosis final del tratamiento del estudio). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: No efficacy endpoints will be evaluated in this study. Safety: Safety will be evaluated based on the incidence of treatment emergent AEs (TEAEs; including treatment discontinuation and dose modifications due to AEs), SAEs, AESIs, changes in ECOG performance status, changes in clinical laboratory assessments (hematology and chemistry), vital sign measurements, observations during physical examination, and use of concomitant medications (excluding any study drugs used in the parent study). All AEs will be coded using the Medical Dictionary for Regulatory Activities coding system outlined in the statistical analysis plan. |
Eficacia: En este estudio no se evaluarán criterios de valoración de eficacia. Seguridad: La seguridad se evaluará en función de la incidencia de AA emergentes del tratamiento (AAET; incluida la interrupción del tratamiento y las modificaciones de la dosis debido a AA), AAG, AAEI, cambios en el estado funcional del ECOG, cambios en las evaluaciones de laboratorio clínico (hematología y química), mediciones de constantes vitales, observaciones durante la exploración física y uso de medicamentos concomitantes (excluyendo cualquier medicamento del estudio usado en el estudio principal). Todos los AA se codificarán utilizando el sistema de codificación del Diccionario médico para actividades reglamentarias descrito en el plan de análisis estadístico. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
as defined in endpoints |
según lo definido en los criterios de evaluación |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
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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 | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 |
Canada |
Israel |
United States |
Austria |
Belgium |
Denmark |
France |
Germany |
Italy |
Spain |
Sweden |
United Kingdom |
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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 | 5 |
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 | 5 |
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 |