E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anaemia in adult patients with solid tumors treated with non-platinum containing chemotherapy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049105 |
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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 the study is to demonstrate that once-weekly NeoRecormon therapy is safe and well tolerated when administered via a 30 000 IU pre-filled syringe in adult patients with solid tumors treated with non-platinum containing chemotherapy. This will be achieved by monitoring of haematology and blood chemistry, blood pressure, and continuous recording of adverse events. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to evaluate the efficacy of NeoRecormon 30 000 IU once weekly in the treatment of anaemia in adult patients with solid tumors treated with non-platinum containing chemotherapy with emphasis on achieving a rapid haemoglobin increase (> 1 g/dL), i.e. after 4 weeks. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
•Adult (≥ 18 years) patients with solid tumors treated with non-platinum containing chemotherapy, which is scheduled for at least 12 weeks •Haemoglobin <= 11 g/dL at visit 1 •WHO performance status grade 0-2 •Life expectancy > 6 months •Written informed consent
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E.4 | Principal exclusion criteria |
•Transfusion of red blood cells during the 2 months prior to first planned dose of study medication •Therapy-resistant hypertension (sitting systolic blood pressure ≥ 170 mmHg and diastolic blood pressure ≥ 110 mmHg) •Known clinically relevant acute or chronic bleeding, i.e. requiring therapy within 3 months prior to planned start of study treatment, e.g. patient with anaemia caused by gastrointestinal bleeding •Known vitamin B12 deficiency, e.g. erythrocyte MCV > 105 fL •Known folic acid deficiency, e.g. erythrocyte MCV > 105 fL •Known haemolysis: haptoglobin < 30mg/dL (3.54 µmol/L) or other reliable positive test of haemolysis •Patients scheduled to receive bone marrow transplantation during the study treatment period •Platelet count < 50 or > 450 x 109/L at visit 1 •Epilepsy •Pregnancy or lactation period •Any unregistered drug in the 30 days preceding the first dose of the study medication or during the study •Patients who previously completed or prematurely withdrew from this study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study variable is defined as the overall incidence of patients reporting adverse events after study medication start. Adverse events will be coded using de MEDdra dictionary. Frequencies and exact 95% confidence intervals will be calculated for the number of patients reporting adverse events, overall and by body system.
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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 | 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 | 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.8.5 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |