E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In an open randomised, multi-center study to identify the haematopoietic response to Aranesp® (Darbepoetin 6,75 mcg/kg) administrated every fourth week compared to standard care of treatment in patients with anaemia due to hormone refractory prostate cancer with progression of skeletal metastases. A haematopoietic response is defined as haemoglobin concentration > 12 g/dl or increase in haemoglobin > 2 g/dl during the treatment phase. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038444 |
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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 |
In an open randomised, multi-center study to identify the haematopoietic response to Aranesp® (Darbepoetin 6,75 mcg/kg) administrated every fourth week compared to standard care of treatment in patients with anaemia due to hormone refractory prostate cancer with progression of skeletal metastases. A haematopoietic response is defined as haemoglobin concentration > 12 g/dl or increase in haemoglobin > 2 g/dl during the treatment phase. |
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E.2.2 | Secondary objectives of the trial |
• To study the effect of Aranesp® (Darbepoetin 6,75 mcg/kg) administrated Q4W compared to standard care of treatment on the Quality of Life in patients with anaemia due to hormone refractory prostate cancer. • To evaluate the necessity for blood transfusion. • To study the effect of Aranesp ® 500 mcg administrated Q4W compared to standard care of treatment on the change in haemoglobin. • To study the haematopoietic response after 8 and 20 weeks of Aranesp® 500 mcg treatment in the subgroup of patients defined as non-responders by an increase in haemoglobin less than 1 g/dl (0,6 mmol/l) at week 8. To register the number of days admitted to hospital during the study period due to treatment of anaemia caused by prostate cancer disease.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Histologically proven prostate cell carcinoma. • Progression in PSA (10% elevation of nadir-value documented by two tests) at least 4 months after surgical orchiectomy or initiation of LHRH-agonist. Testosterone level must be below castration level. • All PSA values must be > 5 ng/ml. • Haemoglobin level below 11 g/dl (6.8 mmol/l). • A life expectancy of more than 3 months. • Informed consent according to local and national regulations. • |
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E.4 | Principal exclusion criteria |
No hypertension (diastolic blood pressure > 100 mmHg), refractory to treatment. • No symptomatic cardiovascular disease or previous history of seizure and with history of thromboembolic events. • clinical significant inflammatory disease. • concomitant or previous malignancies, which are likely to influence the treatment, evaluation and outcome of the current disease and therapy. • concern of subject’s compliance with the protocol procedures. • previously included into the study. • Informed consent according to local and national regulations. • received any erythropoietic therapy within 4 weeks before inclusion into the study. • known positive antibody reaction to any erythropoietic agent.
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E.5 End points |
E.5.1 | Primary end point(s) |
Haemoglobin level at 0, 4, 8, 12, 16 and 20 weeks after start of Aranesp®. Quality of life assesments at 0, 10 and 20 weeks after start of Aranesp®. |
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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 | No |
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 | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
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) | Yes |
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.8.5 | 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 | Information not present in EudraCT |
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 objective of this trial is to investigate, the effect of Aranesp® on haematopoietic response compared to the standard treatment (BSC) of anemia in patients with advanced hormone refractory prostate cancer. The principal endpoint is the number of patients reaching hematopoietic response. The expected recruitment rate is 50-75 patients/year. The trial is planned to be open to recruitment for 2-3 years.
End of trial is planed 15 weeks after last subject has been randomized |
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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 | |
E.8.9.1 | In the Member State concerned days | |