E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent Glioblastoam multiforme |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018337 |
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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 objectives of the study are to assess the safety and tolerability of the implantation of the NeuroPath System, and the stimulation of the SPG in patients with glioblastoma multiforme GBM during chemotherapy with Paclitaxel. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the feasibility of NeuroPath stimulation in improving the bioavailability of Paclitaxel and on the progression of GBM disease in inoperable and recurrent GBM patients measured by MRI or CT. Furthermore to assess Patient survival and measurement of Paclitaxel levels in the plasma and CSF. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Patient with histologically proven classified glioblastoma multiforme. - Disease Inoperable evidence of inability to surgically remove the tumor size,significant infiltration etc ; - Disease recurrence evidence of tumor growth resistant or recurrence per imaging CT or MRI or PET following prior surgery and radiotherapy. At least 4 weeks has elapsed from the last treatment modality radiotherapy or chemotherapy that the patient has received until the beginning of the second Part of the study PART II . Successfully passing part I of the clinical trial, approval of Radiologist and PI that Gadolinium DTPA has passed the BBB measured by the difference from the baseline enhanced MRI without stimulation and enhanced MRI after stimulation. |
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E.4 | Principal exclusion criteria |
- Pregnancy - Severe cardiac or pulmonary disease. - Severe preexisting motor or sensory neurotoxicity greater than grade 2 NCI criteria . - Serious systemic infection. - Local infection in the operation area. - Coagulopathy preventing the patient from undergoing surgery. - Known sensitivity to Paclitaxel, Gadolinium DTPA or to local or general anesthetic. - Received Paclitaxel treatment in the past - Severe disabling CNS disorder not related to the tumor. - Have other electrical or electromagnetic implantable devices. - Currently participating in any other trials. - Patients that have undergone SPG ablation in the past. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assess the safety and tolerability of the device implantation of the NeuroPath System, and the stimulation of the SPG in patients with glioblastoma multiforme GBM during chemotherapy with Paclitaxel. |
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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 | 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) | 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 | 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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |