Merck: Patient Enrollment Completed for Cilengitide’s Pivotal Phase III Trial CENTRIC
CENTRIC study evaluating the efficacy and safety of cilengitide, an integrin inhibitor, in the first-line treatment of glioblastoma patients in combination with standard therapy
Merck KGaA announced that patient enrollment in the global pivotal Phase III clinical study CENTRICa has been completed. CENTRIC was designed to assess the efficacy and safety of the investigational integrin inhibitor Cilengitide in combination with standard treatment in a biomarker-defined subgroup of newly diagnosed patients with glioblastoma (GBM). More than 500 patients have been successfully recruited into this global trial. The primary endpoint of the study is overall survival.
“Completing patient enrollment in the CENTRIC study is a very exciting milestone for us and takes us a step closer to evaluating the efficacy and safety of cilengitide in patients with this aggressive form of brain cancer, an area of high unmet medical need,” said Dr. Oliver Kisker, Senior Vice President for the Global Clinical Development Unit, Oncology at Merck Serono.
Developed in Merck Serono’s own laboratories in scientific collaboration with external partners, cilengitide is the first in a new class of investigational anti-cancer therapies, known as integrin inhibitors, to reach Phase III development. Cilengitide is thought to control tumor growth by working in two ways: through attacking the tumor cells directly in a targeted manner and through starving tumor cells by stopping the formation of new blood vessels that feed the tumor. Cilengitide is an investigational agent and has not been approved for commercial distribution.
Cilengitide’s clinical development program
CENTRIC is a randomized Phase III clinical trial assessing the efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment (radiotherapy plus temozolomide, followed by temozolomide maintenance therapy) versus standard treatment alone in newly diagnosed glioblastoma patients with a methylated methylguanine-DNA methyltransferase (MGMT) gene promoter in the tumor tissue. Other exploratory randomized controlled cilengitide trials currently underway include the Phase I/II COREb companion trial investigating cilengitide in newly diagnosed glioblastoma patients with an unmethylated MGMT gene promoter in the tumor tissue, the Phase I/II CERTOc trial in non-small cell lung cancer and the Phase I/II ADVANTAGEd trial in squamous cell carcinoma of the head and neck.
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