E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with recurrent GBM |
|
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 | 10018336 |
E.1.2 | Term | Glioblastoma |
|
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 principal objective of the trial is to assess the therapeutic activity of ZK 219477 in patients with recurrent glioblastoma. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are the documentation of the safety profile, the mechanism of action and the pharmacokinetic of ZK 219477. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients with histologically proven glioblastoma.
♦ Recurrent disease documented by MRI after failing prior therapy
(usually standard RT with concomitant and maintenance
temozolomide).
♦ Patients with multifocal disease not amenable to radiotherapy are
eligible, provided they have received no or no more than 1 line of prior
chemotherapy.
♦ Presence of at least one bidimensionally measurable target lesion
(contrast enhancing lesion) with a largest diameter of at least 2cm,
based on MRI scan done within two weeks prior to the registration |
|
E.4 | Principal exclusion criteria |
No prior treatment with high dose radiotherapy (> 65 Gy), stereotactic
radiosurgery or internal radiation therapy unless the recurrence is
EORTC 26061 Epothilone in GBM
Version 1.0 8 / 67 31 May, 2006
subsequently histologically confirmed.
♦ Patients must not be taking antiepileptic agents or be on non-enzyme
inducing antiepileptic drugs (non-EIAED). Patients taking phenytoin,
carbamazepin or phenobarbital are not eligible.
No previous or current malignancy at other sites with the exception of
cone biopsied carcinoma of the cervix and adequately treated basal or
squamous cell skin carcinoma.
Females must not be pregnant at entry or lactating. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is success rate being defined as:
♦ either complete or partial response
♦ or a progression free survival at 6 months |
|
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 | Yes |
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 | 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) | 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
| 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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |