Newly diagnosed Glioblastoma (Astrocytoma, WHO grade IV) MedDRA version: 7.1 Level: LLT Classification code 10018336
Conditions
Interventions
Product Name: Cilengitide
Product Code: EMD121974
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cilengitide
CAS Number: 188968-51-6
Current Sponsor code: EMD121974
Co
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent obtained before undergoing any study-related activities - Males or females = 18 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Planned surgery for other diseases (e. g., dental extraction). - History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment. - History of prior malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for = 5 years are eligible for this study. - History of coagulation disorder associated with bleeding or recurrent thrombotic events. - Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety. - Subject is pregnant, anticipates becoming pregnant within 6 months after study participation, or is currently breast-feeding. - Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide. - Prior antiangiogenic therapy. - Placement of Gliadel® wafer at surgery. - Unable to undergo Gd-MRI. - Current alcohol dependence or drug abuse. - Treatment with a prohibited concomitant medication (see Section 6.9.1). - Known hypersensitivity to the study treatment. - Legal incapacity or limited legal capacity. - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before enrollment in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this exploratory study is to estimate the percentage of subjects who survived 6 months without disease progression (6-month PFS). ;Secondary Objective: The secondary objectives are to: · Investigate safety and tolerability. · Investigate the PK of cilengitide and TMZ. · Estimate response rate. · Estimate overall survival time. · Estimate rate of 1-year survival. · Estimate median time to disease progression. Additional goals of the study are: · To increase the safety database in a well defined population of GB subjects (in support of the results from the NABTT-9911 study). · To investigate the relationship between efficacy and alterations in molecular profiles in order to identify molecular markers that correlate with response or resistance. · To measure subject Quality of Life (QoL) by the EORTC- QLQC30 + QLQ BN 20 and the Functional Assessment of Cancer Therapy–Brain (FACT-Br) 1997. ;Primary end point(s): The purpose of the current Phase I/IIa study is to investigate the tolerability and activity of the combination of cilengitide with the newly established treatment regimen (RT and TMZ, followed by maintenance TMZ). The current study is an exploratory, uncontrolled, open-label study, the results of which will be compared to the recently published data of the EORTC Phase III study. The primary endpoint is the rate of subjects alive and progression-free at 6 months (6-month PFS). In the EORTC trial the improvement of PFS correlated with the improvement in overall survival. Therefore this surrogate marker appears to be appropriate for a Phase I/II study. The evaluation of disease progression will be based on radiological and neurological criteria as well as steroid use. | — |
Countries
Belgium, Germany
Outcome results
None listed