E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Non-metastatic or metastatic cancer |
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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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E.2.2 | Secondary objectives of the trial |
• Documentation of tolerability of darolutamide |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All male participants with ongoing darolutamide treatment in Bayer-sponsored feeder studies that do not meet any of treatment/study termination criteria in their respective feeder studies and are eligible to continue receiving treatment with darolutamide. Participants enrolled in a blinded darolutamide study can only be enrolled after study unblinding.
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 with pregnant women and women of child bearing potential (WOCBP) during the study and for 1 week after completion of the treatment. Please refer to Section 8.3.5 for specific details and a list of highly effective contraceptive methods.
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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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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
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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. |
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E.5.2 | Secondary end point(s) |
• Frequency of dose modifications |
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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. |
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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 | 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. |
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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 | 9 |
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 | 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 |
Argentina |
Australia |
Austria |
Belarus |
Belgium |
Brazil |
Bulgaria |
Canada |
Colombia |
Czech Republic |
Estonia |
Finland |
France |
Germany |
Hungary |
Italy |
Japan |
Korea, Republic of |
Latvia |
Lithuania |
Peru |
Poland |
Portugal |
Romania |
Russian Federation |
Serbia |
Slovakia |
South Africa |
Spain |
Sweden |
Taiwan |
Turkey |
Ukraine |
United Kingdom |
United States |
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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
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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. |
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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 |