E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from prostate carcinoma with progression under first line hormonal treatment. Patients entering the study should have a life expectancy prognosis of at least 6 months. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007453 |
E.1.2 | Term | Carcinoma of the prostate metastatic |
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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 assess the progression of the disease and the number of complete clinical responses (according to RECIST20) under treatment with LU901. |
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E.2.2 | Secondary objectives of the trial |
To assess safety and tolerability of treatment with 4PB - To assess quality of life (patient questionnaire) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with a confirmed diagnosis of prostate carcinoma, and measurable metastatic lesion(s). Stage of the disease is T*any*,N*>1* and/or M*>1*, but with a life expectancy of at least 6 months under first-line hormonal treatment. Patient must be at least 21 years of age. Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol. |
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E.4 | Principal exclusion criteria |
Patients with life expectancy < 6 months. Patients with hormonal treatment for prostate carcinoma, initiated within 3 months before start of the study. Patients with non-hormonal treatment for their prostate cancer at study entry. Included patients with rapidly progressive disease (based on clinical judgment of the investigator) requiring second-line treatment (e.g. chemo therapy) will drop out of the study. In case of progression within 6 months after entry into the study, the patient will be replaced, in case of progression after 6 months post-entry, the patient will be regarded as treatment failure. Patients participating in another study protocol. Any condition that would limit the ability to receive oral medication. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). Active second primary malignancy (except adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Primary endpoint: - Tumor progression Secondary endpoint: -Tolerability of treatment |
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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 | 0 |
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 |