E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple solid tumor types. |
Diversi tipi di tumore solido. |
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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. |
Tumore dell'ovaio, delle tube di Fallopio, tumore primario peritoneale, tumore alla prostata metastatico resistente a castrazione (mCRPC) ed altri tumori. |
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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 | 10038977 |
E.1.2 | Term | Retroperitoneal 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 | 10061328 |
E.1.2 | Term | Ovarian epithelial 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 | 10016180 |
E.1.2 | Term | Fallopian tube 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 | 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) |
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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 |
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. |
Fornire un trattamento continuo con rucaparib ai pazienti che hanno partecipato a uno studio sponsorizzato da Clovis e che vengono valutati come in grado di continuare a beneficiare di rucaparib al momento della chiusura dello studio. |
|
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. |
Raccolta di eventi avversi seri (Serious Adverse Events, SAE) ed eventi avversi di particolare interesse (Adverse Events of Special Interest, AESI). Raccogliere i dati relativi al follow-up a lungo termine (LTFU), laddove pertinente, in base agli obiettivi dello studio originario. |
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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 thenecessary 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. |
I pazienti idonei devono essere attualmente arruolati in uno studio su rucaparib sponsorizzato da Clovis che è in fase di chiusura e devono aver firmato e datato un Modulo di consenso informato (Informed Consent Form, ICF) approvato dal Comitato istituzionale di revisione (Institutional Review Board, IRB)/Comitato etico indipendente (CEI); devono attualmente tollerare e trarre beneficio dal trattamento con rucaparib nello studio originario, come valutato dallo sperimentatore, o aver interrotto il trattamento ed essere nel follow-up per la raccolta dei dati dell’LTFU; aver dimostrato conformità ai requisiti dello studio originario ed essere in grado e disposti a rispettare le necessarie visite e valutazioni dello studio nell’ambito dello studio di roll-over e per i pazienti che proseguono il trattamento con rucaparib, non aver ricevuto alcuna terapia antitumorale interventistica dopo l’interruzione dello studio originario. |
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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. |
I pazienti saranno esclusi dall’ulteriore trattamento con rucaparib se sono stati definitivamente ritirati dallo studio originario, per qualsiasi motivo. Le donne in età fertile (Women Of Childbearing Potential, WOCBP) non devono prendere in considerazione la possibilità di avviare una gravidanza durante il trattamento continuato e per 6 mesi dopo l’ultima dose di rucaparib. Sono esclusi i pazienti di sesso maschile con partner in età fertile o in gravidanza che si rifiutino di utilizzare un metodo contraccettivo efficace durante il trattamento e per 3 mesi dopo l’ultima dose di rucaparib. Saranno esclusi anche i pazienti di sesso maschile che stanno valutando la possibilità di effettuare donazioni di liquido seminale durante il trattamento o entro 3 mesi dall’ultima dose di rucaparib. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
No secondary endpoints. |
Nessuno. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
No secondary timepoints. |
Nessuno. |
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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 | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 5 |
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 | Information not present in EudraCT |
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 |
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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
|
Treatment should be continued until it is determined by the investigator that no further clinical benefit can be achieved. |
Il trattamento dovrebbe continuare fino a che lo sperimentatore non decide che non può essere più ottenuto alcun beneficio clinico. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
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 | 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 |