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The purpose of this study is to explore the efficacy and safety of Atorvastatin in combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The anticipated time on study treatment is until disease progression, and the target sample size is 32 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin in Combination With Radiotherapy and Temozolomide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival at 6 months (PFS-6) | All efficacy determinations will be based on the Response Assessment in Neuro-Oncology (RANO) response criteria (Wen 2010) | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival defined as the time the patient enters the study until first progression or death whichever occurs first | Up to 2-3 years |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdullah K. Altwairgi, MD | King Fahad Medical City | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Fahad Medical City | Riyadh | 11525 | Saudi Arabia |
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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 |
|---|---|
| D000069059 | Atorvastatin |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Temozolomide | Drug | 75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy |
|
| Radiotherapy | Radiation | 60 Gy in 30 fractions |
|
Overall Survival defined as the time the patient enters the study to the date of death due to any cause.
| Up to 2-3 years |
| Adverse events | The assessment of safety will be based on the frequency of Adverse Events graded (grade 3+) according to the Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.0 scoring system. | Up to 2-3 years |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D013812 | Therapeutics |