E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
newly diagnosed intrinsic pontine gliomas of children and adolescents |
|
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 | 10018338 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the progression-free survival PFS of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy in newly diagnosed intrinsic pontine gliomas |
|
E.2.2 | Secondary objectives of the trial |
To determine the progression-free survival PFS of the combination of monoclonal anti-EGFR antibody OSAG 101 and standard local radiotherapy in newly diagnosed intrinsic pontine gliomas |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Newly diagnosed intrinsic pontine glioma documented in MRI and measurable in at least one dimension Age o 3 3 years to o 20 years, both gender Life expectancy o 4 weeks Performance status ECOG o 3 or Karnofsky/Lansky status o 40 Adequate hematological, renal, and hepatic function |
|
E.4 | Principal exclusion criteria |
Pontine glioma as secondary malignancy Low grade brain stem glioma i.e. focal, cervicomedullar, tectal brain stem glioma Other severe underlying disease or pre-existing serious conditions which bear the risk of an inadequate study treatment e.g. severe mental retardation, severe statomotoric retardation, severe cerebral palsy, congenital syndromes Prior antineoplastic therapy, inclusively chemotherapy, immunotherapy, radiotherapy Prior administration of a recombinant human or mural antibody or known hypersensitivity to antibodies Simultaneously other antineoplastic therapy than the study treatment Participation in another therapeutic study or experimental treatment involving the underlying cancer disease Pregnancy, lactating mother and inadequate contraception in females and males of childbearing age |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Probability of a patient to survive progression-free 6 months after diagnosis |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |