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NCT00813943 · ClinicalTrials.gov registry record · Phase 2
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 265
- Enrollment target
NCT00813943 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 265 participants.
The verdict
NCT00813943, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 265 participants
- Enrollment target
Study Summary
CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue. The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to appear to be a predictive marker for benefit from temozolomide (TMZ) treatment. In a safety run-in period in dedicated study centers, the safety and tolerability of Cilengitide given as an intense treatment in combination with the first part of standard therapy will be assessed. Thereafter the trial will investigate the overall survival and progression-free survival in subjects receiving two different regimens of Cilengitide in combination with standard treatment versus standard treatment alone.
Interventions
- DRUG Temozolomide
- RADIATION Radiotherapy
- DRUG Cilengitide (2-times weekly)
- DRUG cilengitide (5-times weekly)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00813943
The ClinicalTrials.gov registry entry for NCT00813943 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT00813943 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00813943 about?
NCT00813943 is a clinical study titled "Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status". CORE is a Phase 2 clinical trial in newly diagnosed glioblastoma in subjects with an unmethylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue. The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element ...
What is the current status of trial NCT00813943?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2009-03. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00813943?
The interventions under investigation include: Temozolomide (DRUG), Radiotherapy (RADIATION), Cilengitide (2-times weekly) (DRUG), cilengitide (5-times weekly) (DRUG).
Who is sponsoring clinical trial NCT00813943?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
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