E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced ovarian, breast, or prostate cancer |
carcinoma ovarico, mammario o prostatico avanzato |
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E.1.1.1 | Medical condition in easily understood language |
advanced ovarian, breast, or prostate cancer |
carcinoma ovarico, mammario o prostatico avanzato |
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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) |
|
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 |
Valutare la sicurezza e la tollerabilità a lungo termine di niraparib |
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E.2.2 | Secondary objectives of the trial |
No secondary objectives will be evaluated in this study. |
Nessun obiettivo secondario sarà valutato in questo studio. |
|
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. Il soggetto è in grado di comprendere le procedure dello studio e accetta di partecipare allo studio fornendo il consenso informato scritto. 2. Il soggetto è disposto e in grado di ottemperare alle visite programmate, al piano di trattamento e qualsiasi altra procedura di studio. 3. Il soggetto è attualmente in trattamento con niraparib ( monoterapia o in combinazione) in uno studio sponsorizzato da GSK / TESARO che ha soddisfatto i requisiti per l'obiettivo primario. 4. Il soggetto sta attualmente beneficiando del trattamento con niraparib come valutato dallo sperimentatore secondo i requisiti del protocollo dello studio genitore. 5. Soggetti in età fertile che sono sessualmente attivi e i loro partner devono accettare l'uso di una forma efficace di contraccezione durante la loro partecipazione al trattamento in studio per 180 giorni dopo l'ultima dose del farmaco in studio. |
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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. Il soggetto ha dovuto interrompere definitivamente il trattamento con niraparib nello studio genitore per un qualsiasi motivo. 2. Il soggetto ha attualmente tossicità irrisolte per le quali il dosaggio di niraparib è stato interrotto nello studio genitore. Soggetti che incontrano tutti gli altri criteri di ammissibilità possono essere registrati una volta che le tossicità si sono risolte in modo da riprendere il trattamento con niraparib. 3. Il soggetto è incinta o concepirà un bambino mentre sta ricevendo il farmaco in studio o fino a 180 giorni dopo l'ultima dose di farmaco in studio. Il soggetto sta allattando o allatterà entro 30 giorni dal ricevimento della dose finale del farmaco in studio (le donne non dovrebbero allattare o conservare il latte materno per l'uso durante il trattamento con niraparib e per 30 giorni dopo aver ricevuto la dose finale del trattamento in studio). |
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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. |
Efficacia: Nessun endpoint di efficacia sarà valutato in questo studio. Sicurezza: La sicurezza sarà valutata in base all'incidenza del trattamento emergente AEs (TEAEs; compresa l'interruzione del trattamento e le modifiche della dose a causa di eventi avversi), SAEs, AESIs, modifiche allo stato delle prestazioni ECOG, modifiche nelle valutazioni cliniche di laboratorio (ematologia e chimica), segni vitali misurazioni, osservazioni durante l'esame fisico e uso di farmaci concomitanti (esclusi eventuali farmaci in studio utilizzati nello studio genitore). Tutti gli AEs verranno codificati utilizzando il Dizionario Medico per le Attività Regolatorie del sistema di codifica delineato nel piano di analisi statistica. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
as defined in endpoints |
come definito negli endpoints |
|
E.5.2 | Secondary end point(s) |
not applicable |
non applicabile |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
non applicabile |
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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 |
Tollerabilità |
|
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 | 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 |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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 |
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
|
|
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 |