E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer) |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062904 |
E.1.2 | Term | Hormone-refractory 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 |
The primary objective of this extension study is to gain more information about the long-term safety and tolerability of ODM-201. |
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E.2.2 | Secondary objectives of the trial |
Antitumour activity of ODM-201 will be evaluated by PSA response, changes in soft tissue and bone lesions, Eastern Cooperative Oncology Group (ECOG) performance status, and by the time on treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Written informed consent (IC) obtained.
2.Patients who successfully completed 12 weeks of treatment according to study protocol 3104001, without any serious drug-related AEs or DLT.
3.Patient is expected to benefit from participation in the study in the opinion of the investigator.
4.Patients with any response or stable disease in study 3104001 at week 12. 5.Sexually active patients must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the treatment. |
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E.4 | Principal exclusion criteria |
1.New serious concurrent medical condition or psychiatric illness.
2.Any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures. 3.The patient is not able to swallow the study treatment capsules. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate safety and tolerability of ODM-201 by assessing the adverse events using the NCI CTCAE version 4.03. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety & tolerability evaluation at baseline (week 12 of study 3104001), then monthly for the first 6 months and then in 3-month intervals and at the end-of study visit. |
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E.5.2 | Secondary end point(s) |
Evaluation of efficacy by using assessing of PSA response, ECOG performance status, soft tissues changes and bone lesions. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
PSA is evaluated at baseline (week 12 of study 3104001), then monthly for the first 6 months and then in 3-month intervals and at the end-ofstudy visit.
ECOG performance status at baseline and then every 3 months. Soft tissues changes and bone lesions are evaluated at baseline and then every 3 months, except for patients with no bone metastases or bone pain at baseline, the bone evalauation will be performed every 6 months. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | 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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
Czech Republic |
Finland |
France |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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For all patients (including discontinued patients) there is a 4-week post-treatment period after the end of the study treatment. After this, the end-of-study visit will take place. |
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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 | 2 |
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 | 2 |
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 |