E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Non-metastatic or metastatic cancer |
Carcinomi non-metastatici o metastatici |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
• Continuation of darolutamide treatment • Safety of darolutamide
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· Prosecuzione del trattamento con darolutamide · Sicurezza di darolutamide |
|
E.2.2 | Secondary objectives of the trial |
• Documentation of tolerability of darolutamide |
· Documentazione di tollerabilità di darolutamide |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol 2. Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment. 3. Participants who have not met any treatment discontinuation criteria outlined in the feeder study protocol. 4. Willingness to continue practicing acceptable methods of birth control during the study.
|
1. Capacità di fornire il consenso informato firmato, come descritto nell’Appendice 1, che include la conformità ai requisiti e alle restrizioni elencati nel modulo di consenso informato (ICF) e in questo protocollo 2. Partecipanti arruolati in uno degli studi originali con darolutamide sponsorizzato da Bayer alla data della conclusione o del completamento primario dello studio, che stanno attualmente assumendo darolutamide e manifestando un beneficio clinico derivante dal trattamento. 3. Partecipanti che non hanno soddisfatto nessuno dei criteri di interruzione del trattamento indicati nel protocollo dello studio di origine. 4. Volontà di continuare ad applicare metodi contraccettivi adeguati durante lo studio. |
|
E.4 | Principal exclusion criteria |
1. Participant is unable to comply with the requirements of the study. 2. Negative benefit/ risk ratio as determined by the investigator. 3. Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
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1. Il partecipante non è in grado di attenersi a quanto previsto dallo studio. 2. Rapporto rischi/benefici sfavorevole, secondo quanto stabilito dallo sperimentatore. 3. Il partecipante soddisfa uno qualsiasi dei criteri di interruzione del trattamento dello studio di origine da cui proviene. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Incidence of TEAEs (Treatment-emergent adverse events) • Incidence of TESAEs (Treatment-emergent serious adverse events) • Incidence of drug-related TEAEs and TESAEs
|
Incidenza di TEAE a Incidenza di TESAE a Incidenza di TEAE e TESAE correlati al farmaco in studio |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
These will be summarized formally at the end of the study when all patients are complete. |
Verranno formalmente riassunti al completamento dei Pazienti a fine studio. |
|
E.5.2 | Secondary end point(s) |
• Frequency of dose modifications |
Frequenza delle modifiche della dose |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
These will be summarized formally at the end of the study when all patients are complete. |
Verranno formalmente riassunti al completamento dei Pazienti a fine studio. |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
The purpose of this study is to enable participants who are receiving darolutamide in any Bayer-sponsored feeder study, and assessed by the investigator to be benefitting, to continue to receive darolutamide treatment beyond the feeder study primary completion or closure. |
Lo scopo di questo studio è quello di consentire ai pazienti che stiano ricevendo darolutamide in qualsiasi studio sponsorizzato da Bayer siano valutati dallo sperimentatore come aventi un beneficio dal trattamento, di continuare a ricevere darolutamide oltre il completamento o la chiusura dello studio di origine. |
|
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.8.2.4 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 165 |
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 |
Australia |
Belarus |
Brazil |
Canada |
Colombia |
Japan |
Korea, Republic of |
Peru |
Russian Federation |
South Africa |
Taiwan |
Turkey |
Ukraine |
United States |
Austria |
Belgium |
Bulgaria |
Estonia |
Finland |
France |
Germany |
Hungary |
Italy |
Latvia |
Lithuania |
Poland |
Portugal |
Romania |
Slovakia |
Spain |
Sweden |
United Kingdom |
Czechia |
Argentina |
|
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 study is defined as the date when the last participant from the last feeder study has completed the roll-over study or the sponsor has decided to close the trial. |
La fine studio viene definita dalla data in cui l'ultimo Paziente dell'ultimo studio di origine completerà lo studio roll-over , oppure dalla data in cui lo Sponsor deciderà di chiudere lo studio |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 18 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 18 |