Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by EMD Serono.
NCT00813943 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 265 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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 |
What the finished NCT00813943 record still lists
NCT00813943 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher).
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT00813943 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00813943's enrollment target sits among peer trials
265 210th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05443126 · 265 participants · Phase 1
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
- NCT05470491 · 265 participants · Phase 1
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
- NCT07301905 · 265 participants · NA
Culturally Targeted Health Communication and Receptivity to the Human Papillomavirus Vaccine Among Parents in Flint, MI
- NCT07470853 · 265 participants · Phase 1
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia