Cilengitide in 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
- 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-CZ
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
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 <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
1. Prior chemotherapy within the last 5 years.
2. Prior RTX of the head (except for low dose radiotherapy 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Overall survival time;Main Objective: Overall survival time;Secondary Objective: ·PFS time (main focus on 6-month PFS)<br>·Quality of Life (EORTC-QLQ30 and QLQBN20),general health status (EQ-5D), health care resource utilization, and work status<br>·Safety and tolerability<br>·Population PK of cilengitide
- Secondary Outcome Measures
Name Time Method