E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple solid tumor types |
Múltiples tipos de tumores sólidos |
|
E.1.1.1 | Medical condition in easily understood language |
Ovarian, Fallopian Tube, Primary Peritoneal Cancer, metastatic castration-resistant prostate cancer (mCRPC) and other tumours |
Cáncer de ovario, de trompas de Falopio, primario de peritoneo, cáncer de próstata resistente a la castración (mCRPC) y otros tumores |
|
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 | 10038977 |
E.1.2 | Term | Retroperitoneal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 | 10061328 |
E.1.2 | Term | Ovarian epithelial cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 | 10016180 |
E.1.2 | Term | Fallopian tube cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
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) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076506 |
E.1.2 | Term | Castration-resistant prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
Provide ongoing rucaparib treatment to patients who participated in a Clovis-sponsored study and who are assessed as continuing to benefit from rucaparib at the time of study closure; |
Proporcionar un tratamiento continuo con rucaparib a los pacientes que participaron en un estudio patrocinado por Clovis y que se considera que siguen beneficiándose de rucaparib en el momento del cierre del estudio; |
|
E.2.2 | Secondary objectives of the trial |
Collect serious adverse events (SAEs) and adverse events of special interest (AESIs)
Collect long-term follow-up (LTFU) data, as applicable based on parent study objectives. |
Recoger los acontecimientos adversos graves (SAEs) y los acontecimientos adversos de especial interés (AESIs)
Recoger datos de seguimiento a largo plazo (LTFU), según corresponda en función de los objetivos del estudio principal. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Eligible patients must be currently enrolled in a Clovis-sponsored study of rucaparib that is being closed and have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF); are currently tolerating and benefitting from rucaparib treatment in the parent study, as assessed by the investigator, or have discontinued treatment and be in follow-up for collection of LTFU data; have demonstrated compliance with the parent study requirements and are able and willing to comply with the necessary study visits and assessments as part of the rollover study; and for patients continuing treatment with rucaparib, have not received any intervening anticancer therapy since discontinuing the parent study. |
Los pacientes elegibles deben estar actualmente inscritos en un estudio de rucaparib patrocinado por Clovis que se esté cerrando y haber firmado y fechado un Formulario de Consentimiento Informado (FCI) aprobado por la Junta de Revisión Institucional (IRB)/Comité de Ética Independiente (IEC); estar tolerando y beneficiándose del tratamiento con rucaparib en el estudio principal, según la evaluación del investigador, o haber interrumpido el tratamiento y estar en seguimiento para la recolección de datos del LTFU; haber demostrado el cumplimiento de los requisitos del estudio principal y ser capaz y estar dispuesto a cumplir con las visitas y evaluaciones necesarias como parte del estudio de renovación; y en el caso de los pacientes que continúen el tratamiento con rucaparib, no haber recibido ninguna terapia anticancerígena de intervención desde la interrupción del estudio principal. |
|
E.4 | Principal exclusion criteria |
Patients will be excluded from receiving further rucaparib treatment if they have been permanently discontinued from rucaparib in the parent study for any reason. Women of childbearing potential (WOCBP) must not be considering getting pregnant during continued treatment and for 6 months following the last dose of rucaparib. Male patients with female partners of reproductive potential or who are pregnant who refuse to use effective contraception during treatment and for 3 months following the last dose of rucaparib are excluded. Male patients who are considering making semen donations during treatment or within 3 months following the last dose of rucaparib will also be excluded. |
Las pacientes serán excluidas de recibir más tratamiento con rucaparib si se les ha suspendido permanentemente el rucaparib en el estudio principal por cualquier motivo. Las mujeres en edad fértil (WOCBP) no deben considerar la posibilidad de quedarse embarazadas durante el tratamiento continuado y durante los 6 meses siguientes a la última dosis de rucaparib. Quedan excluidos los pacientes varones con parejas femeninas con potencial reproductivo o embarazadas que se nieguen a utilizar métodos anticonceptivos eficaces durante el tratamiento y durante los 3 meses siguientes a la última dosis de rucaparib. También se excluirán los pacientes varones que consideren hacer donaciones de semen durante el tratamiento o en los 3 meses siguientes a la última dosis de rucaparib. |
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E.5 End points |
E.5.1 | Primary end point(s) |
No end points |
No hay variables principales |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
No timepoints |
No hay momentos de evaluación |
|
E.5.2 | Secondary end point(s) |
No secondary endpoints |
No hay variables secundarias |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
No secondary timepoints |
No hay momentos de evaluación de la variable secundaria |
|
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 | Yes |
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 | 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.8.2.4 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
Brazil |
Canada |
Israel |
Russian Federation |
Ukraine |
Hungary |
Italy |
Poland |
Spain |
United Kingdom |
Czechia |
|
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
|
Treatment should be continued until it is determined by the investigator that no further clinical benefit can be achieved |
El tratamiento debe continuarse hasta que el investigador determine que ya no se puede obtener ningún beneficio clínico |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
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 |