Newly diagnosed, histologically proven GBM with proven methylated MGMT gene promoter status MedDRA version: 15.1 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Cilengitide
Product Code: EMD 121974
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cilengitide
CAS Number: 188968-51-6
Current Sponsor code: EMD121974
Concentration uni
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Tumor tissue specimens from the GBM surgery or open biopsy (formalin-fixed, paraffin-embedded block; stereotactic biopsy not allowed) must be available for MGMT status analysis and central pathology review. 2. Newly diagnosed histologically proven supratentorial GBM (World Health Organization [WHO] Grade IV). 3. Proven methylated MGMT gene promoter methylation status. 4. Available post-operative Gd-MRI performed within =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy within the last 5 years. 2. Prior RTX of the head (except for low dose radiotheray for Tinea capitis). 3. Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide. 4. Prior systemic antiangiogenic therapy. 5. Placement of Gliadel® wafer at surgery. 6. Inability to undergo Gd-MRI. 7. Planned major surgery for other diseases. 8. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment. 9. History of 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. 10. History of coagulation disorder associated with bleeding or recurrent thrombotic events. 11. Clinically manifest myocardial insufficiency (NYHA III, IV) or history of myocardial infarction during the past 6 months. Uncontrolled arterial hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess overall survival time;Secondary Objective: Assess: ·PFS time (main focus on 6-month PFS) ·Quality of Life (EORTC-QLQ30 and QLQBN20),general health status (EQ-5D), health care resource utilization, and work status ·Safety and tolerability ·Population PK of cilengitide;Primary end point(s): Overall survival time;Timepoint(s) of evaluation of this end point: Various timepoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability, PFS, QoL and population PK;Timepoint(s) of evaluation of this end point: Various timepoints | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Slovakia, Spain, United Kingdom
Contacts
Public ContactCommunication Centre
Merck KGaA
Outcome results
None listed