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| Sponsor: | EMD Serono |
|---|---|
| Collaborator: |
European Organization for Research and Treatment of Cancer - EORTC |
| Information provided by: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00689221 |
Purpose
CENTRIC is a Phase III clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma multiforme (GBM) patients with a methylated promoter of the methylguanine-DNA methyltransferase (MGMT) gene in the tumor tissue.
The MGMT gene promoter is a section of DNA that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Drug: Cilengitide, Temozolomide & Radiotherapy Drug: Temozolomide & Radiotherapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cilengitide for Subjects With Newly Diagnosed Glioblastoma Multiforme and Methylated MGMT Gene Promoter - A Multicenter, Open-label, Controlled Phase III Study, Testing Cilengitide in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy) Versus Standard Treatment Alone |
| Estimated Enrollment: | 504 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cilengitide, Radiotherapy & Temozolomide
|
Drug: Cilengitide, Temozolomide & Radiotherapy
Cilengitide 2000mg i.v. twice weekly, Temozolomide & Radiotherapy
|
|
2
Temozolomide & Radiotherapy
|
Drug: Temozolomide & Radiotherapy
Temozolomide & Radiotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Central US Contact Local Medical Information Office located in | |
| Rockland, Massachusetts, United States | |
| Germany | |
| Central EU Contact Merck KGaA Communication Center located in | |
| Darmstadt, Germany | |
| Study Chair: | Roger Stupp, Dr. med. | Centre pluridisciplinaire d'Oncologie |
More Information
| Responsible Party: | Dr. Martin Picard, Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT00689221 History of Changes |
| Other Study ID Numbers: | EMD 121974-011, EORTC 26071-22072 |
| Study First Received: | May 29, 2008 |
| Last Updated: | July 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
newly diagnosed Glioblastoma (WHO Grade IV) |
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |