E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with increasing clinical symptoms of brain edema caused by brain tumor or brain metatstasis, on maximum dose of corticosteroids will be asked to participate in the study. The brain edema must be confirmed by MRI |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006121 |
E.1.2 | Term | Brain edema |
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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 study is to evaluate the effect of an additional single dose of Kappaproct to corticosteroid treated patients with brain edema caused by brain tumor, measured as reduction of the volume of the edema by MRI |
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E.2.2 | Secondary objectives of the trial |
-Safety and tolerability after one dose of Kappaproct -Pharmacodynamic analyses - In an explorative manner study the immune response in blood from patients before and after the treatment with Kappaproct including cytokine profiles and other factors believed to indicate status of steroid resistance, steroid re-sensitization and effects on the immune system. Examples of factors that will be analyzed are IL-10, IP-10, interferons and specific biomarkers for steroid response and immune system biomarkers such as CD20. -Possible reduction of steroids -Reduction of clinical symptoms of brain edema, judged by the investigator
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adults (>18 year) with malignant brain edema confirmed by MRI, caused by malignant glioma; menigioma or metastatic disease, - WHO/ECOG performance 0- 3 - Betapred (betamethasone) dose 8 mg x 2 for more than 24 hours - Clinical need for increase of corticosteroid dosage - Written informed consent obtained
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E.4 | Principal exclusion criteria |
•History and precence of a clinical significant cardiovascular, hepatic, heamatological, endocrine, neurological and psychiatric disease or immune compromised state as judged by the investigator •Chemotherapy that has been administrated within 4 weeks prior to inclusion. •Positive urine pregnancy test in women at enrolment On treatment with other investigational product
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E.5 End points |
E.5.1 | Primary end point(s) |
Volume of brain edema measured by MRI compared to baseline Record of change in steroid doses (daily changes) Assessment of clinical symptoms (assessed by the investigator) |
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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 | 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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| 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 | 2 |
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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The 10 first patients will be evaluated before any more patients are included. Clinical assessment, daily dose of corticosteroids and volume of the brain edema, measured with MRI will be evaluated. The investigators and the sponsor will together make a decision if the study shall continue or not considered the results.
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |