E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the safety and efficacy of Gliadel and Temozolomide as adjunctive treatment with surgery and external beam radiotherapy in newly diagnosed glioblastoma patients |
|
E.2.2 | Secondary objectives of the trial |
Toxicities, PFS, Median Survival Time |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signed and dated IRB-approved Informed Consent. Supratentorial, single tumor, without radiological signs of leptomeningeal diffusion. Histologically proven Glioblastoma Multiforme (GBM) following maximal resection of tumor ( ≥ 95%). Age ≥ 18 years KPS ≥ 70 Life expectancy of at least 3 months. Negative pregnancy test (if female in reproductive years) Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the entire duration of study participation, if men and women with child-producing potential. Acceptable liver function: - Bilirubin  1.5 upper limit of normal (ULN) - Albumin  3.0 g/dL - AST (SGOT), ALT (SGPT)  2.5 ULN (if liver metastases are present, then  5 ULN is allowed) - Alkaline phosphatase  2.5 ULN (if liver and/or bone metastases are present, then  5 ULN is allowed) Acceptable renal function: Serum creatinine ≤1.5 mg/dl (or ≤133 µmol/L) Acceptable hematologic status: - ANC  1,500 cells/mm3 - Platelet count  100,000 cells/mm3 - Hemoglobin  10.0 g/dL. All patients on treatment with anticonvulsants should continue the anticonvulsant therapy with non-enzyme-inducing anticonvulsants (non-EIACs). Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol. |
|
E.4 | Principal exclusion criteria |
Diagnosis different to glioblastoma or gliosarcoma. Proven Glioblastoma Multiforme (GBM) but with resection < of 95 % of tumor. Infratentorial and multifocal Glioblastoma. Glioblastoma with signs of leptomeningeal dissemination. Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1 Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Pregnant or breast feeding women. Known HIV infection, active hepatitis B or hepatitis C. Prior chemotherapy. Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri. Current enrollment in another therapeutic clinical trial. Other severe acute or chronic medical or psychiatric condition or laboratory abnormalities that may increase the risk associated with study participation or may interfere with the interpretation of study results and, on the basis of the investigator judgement, would make the patient inappropriate for this study or could compromise protocol objectives. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
% progeession free survival at 12 months (%PFS-12) |
|
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 | 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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 | 0 |
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 | 0 |