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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zarnestra | Drug | ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy. | ||
| standard Radiation therapy | Procedure | Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy will be assessed by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy | time of study |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (RECIST and volumetric criteria) | time of study | |
| Median survival, 6 month and 1 year survival rates | 6 month and 1 year | |
| Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters |
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Inclusion Criteria:
Exclusion Criteria:
Absolute neutrophil count (ANC) < 1500/mm3 (1.5*109/l) Platelet count <100,000/mm3 (100*109/l)
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth MOYAL, Dr | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | France | ||||
| Institut Claudius Regaud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23566417 | Result | Ducassou A, Uro-Coste E, Verrelle P, Filleron T, Benouaich-Amiel A, Lubrano V, Sol JC, Delisle MB, Favre G, Ken S, Laprie A, De Porre P, Toulas C, Poublanc M, Cohen-Jonathan Moyal E. alphavbeta3 Integrin and Fibroblast growth factor receptor 1 (FGFR1): Prognostic factors in a phase I-II clinical trial associating continuous administration of Tipifarnib with radiotherapy for patients with newly diagnosed glioblastoma. Eur J Cancer. 2013 Jun;49(9):2161-9. doi: 10.1016/j.ejca.2013.02.033. Epub 2013 Apr 6. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C402769 | tipifarnib |
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| time of study |
| Toulouse |
| France |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |