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 (CENTRIC). - ND
- Conditions
- EWLY DIAGNOSED, HISTOLOGICALLY PROVEN GBM WITH PROVEN METHYLATED MGMT GENE PROMOTER STATUSMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme
- Registration Number
- EUCTR2007-004344-78-IT
- Lead Sponsor
- MERCK KGAA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1400
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 <48 hours after surgery (in case it was not possible to obtain a Gd-MRI within <48 hours post surgery, a Gd-MRI is to be performed prior to randomization). 5. Stable or decreasing dose of steroids for ≥5 days prior to randomization 6. ECOG PS of 0-1. 7. Meets 1 of the following RPA classifications: Class III (Age <50 years and ECOG PS 0). Class IV (meeting one of the following criteria: a) Age <50 years and ECOG PS 1 or b) Age ≥50 years, underwent prior partial or total tumor resection, MMSE ≥27). Class V (meeting one of the following criteria: a) Age ≥50 years and underwent prior partial or total tumor resection, MMSE <27 or b) Age ≥50 years and underwent prior tumor biopsy only).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Prior chemotherapy within the last 5 years. 2. Prior RTX of the head. 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 surgery for other diseases (e.g. dental extraction). 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess whether overall survival time in subjects receiving cilengitide (2000 mg twice weekly i.v.) in combination with standard treatment is statistically significantly prolonged compared to subjects receiving standard treatment alone.;Secondary Objective: The secondary objectives of this study are: To compare Progression Free Survival (PFS) time between treatment groups. To investigate safety and tolerability. To investigate the population PK of cilengitide. To measure subject Quality of Life (QoL) by the EORTC-QLQC30 + QLQ BN 20, general health status by the EQ-5D, health care resource utilization, and work status.;Primary end point(s): Overall survival time
- Secondary Outcome Measures
Name Time Method