E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PROSTATE CANCER |
Cancro da próstata |
|
E.1.1.1 | Medical condition in easily understood language |
Non-metastatic or metastatic cancer |
Cancro metastático ou não-metastático |
|
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 | 10060862 |
E.1.2 | Term | 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 |
• Continuation of darolutamide treatment
• Safety of darolutamide
|
- Continuação do tratamento com Darolutamida
- Segurança da Darolutamida |
|
E.2.2 | Secondary objectives of the trial |
• Documentation of tolerability of darolutamide |
- Documentação da tolerabilidade da Darolutamida |
|
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 contraception and birth
control when sexually active with pregnant women during the study and for 1 week
after completion of study treatment. Participants must use effective contraception
while on treatment and for 3 months after completion of study treatment when
sexually active with women of child bearing potential (WOCBP). |
1. Capaz de dar o consentimento informado escrito incluindo conformidade com os requisitos listados no formulário de consentimento informado (PIIC) e no protocolo
2. Participantes inscritos em qualquer ensaio da Bayer com Darolutamida no momento de encerramento do ensaio ou conclusão primária, que estejam a receber atualmente Darolutamida e que estejam a beneficiar clinicamente do tratamento
3. Participantes que não tenham atingido nenhum critério de descontinuação delineado no protocolo do ensaio primário
4. Vontade de continuar a praticar métodos contracetivos aceitáveis e de controlo de natalidade quando sexualmente ativo com mulheres grávidas durante o ensaio e por 1 semana após a conclusão do tratamento do ensaio. Os participantes devem utilizar métodos contraceptivos eficazes durante o tratamento e durante 3 meses após a conclusão do tratamento do ensaio quando sexualmente ativos com mulheres em idade fértil (MEIF). Por favor consultar secção 8.3.5 para detalhes específicos e uma lista de métodos contracetivos altamente efcazes. |
|
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.
|
1. Particpante é incapaz de cumprir com os requerimentos do ensaio
2. Racio negativo da proporção risco/benefício determinado pelo Investigador
3. Preencher qualquer um dos critérios para descontinuação de tratamento no ensaio primário no qual se encontrava a participar |
|
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
|
- incidência de EAET (eventos adversos emergentes do tratamento)
- incidência de EAGET (eventos adversos graves emergentes do tratamento)
- incidência de EAETs e EAGETs relacionados com o medicamento |
|
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. |
Serão sumarizados formalmente no final do ensaio quando todos os participantes tiverem completado o ensaio |
|
E.5.2 | Secondary end point(s) |
• Frequency of dose modifications |
Frequência de modificações de 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. |
Estes serão sumarizados formalmente no final do estudo quando todos os doentes tiverem completado o ensaio. |
|
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. |
O objetivo deste ensaio é permitir que os participantes que estavam a receber darolutamida em qualquer um dos ensaios anteriores promovidos pela Bayer e que, de acordo com o investigador, estavam a beneficiar do tratamento, continuem a receber o tratamento com darolutamida para além da conclusão primária ou do encerramento do ensaio preliminar. |
|
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.8.3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 255 |
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 |
Australia |
Belarus |
Brazil |
Canada |
Colombia |
Japan |
Korea, Republic of |
Peru |
Russian Federation |
Serbia |
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. |
O final do ensaio é definido como a data em que o último participante do ensaio primário tiver completado o ensaio de roll over ou o Promotor tiver decidido encerrar o ensaio |
|
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 |