NCT00689221已完成3 期
Cilengitide for Subjects With Newly Diagnosed Glioblastoma 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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 545
- 试验地点
- 2
- 主要终点
- Overall Survival (OS) Time
研究概览
简要总结
CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue.
The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed, paraffin-embedded block; stereotactic biopsy not allowed) must be available for MGMT status analysis and central pathology review
- •Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV)
- •Proven methylated MGMT gene promoter methylation status
- •Available post-operative gadolinium-enhanced magnetic resonance imaging (Gd-MRI) performed within less than (<) 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)
- •Stable or decreasing dose of steroids for greater than or equal to (>=) 5 days prior to randomization
- •Eastern Cooperative Oncology Group performance score (ECOG PS) of 0-1
- •Meets 1 of the following recursive partitioning analysis (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, mini mental state examination [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)
- •Other protocol defined inclusion criteria could apply
排除标准
- •Prior chemotherapy within the last 5 years
- •Prior RTX of the head
- •Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide
- •Prior systemic antiangiogenic therapy
- •Placement of Gliadel® wafer at surgery
- •Inability to undergo Gd-MRI.
- •Planned surgery for other diseases
- •History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment
- •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
- •History of coagulation disorder associated with bleeding or recurrent thrombotic events
- •Clinically manifest myocardial insufficiency (New York Heart Association [NYHA] III, IV) or history of myocardial infarction during the past 6 months; uncontrolled arterial hypertension
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Cilengitide + Temozolomide + Radiotherapy
Experimental
干预措施: Cilengitide (Drug)
Cilengitide + Temozolomide + Radiotherapy
Experimental
干预措施: Temozolomide (Drug)
Cilengitide + Temozolomide + Radiotherapy
Experimental
干预措施: Radiotherapy (Radiation)
Temozolomide + Radiotherapy
Active Comparator
干预措施: Temozolomide (Drug)
Temozolomide + Radiotherapy
Active Comparator
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Overall Survival (OS) Time
时间窗: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)
The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
次要结局
- Time to Maximum Plasma Concentration (Tmax)(Day 1 of Week -1)
- Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose(Day 1 of Week -1)
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores(Up to 50 months)
- Maximum Observed Plasma Concentration (Cmax)(Day 1 of Week -1)
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores(Up to 50 months)
- Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4(Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012))
- Number of Participants With Change From Baseline in Work Status at End of Study(Baseline, End of study (up to cut-off date, [19 Nov 2012]))
- Progression Free Survival (PFS) Time - Investigator and Independent Read(Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))
- EuroQol 5-Dimensions (EQ-5D) Questionnaire Index(Up to 50 months)
- Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI-CTC Toxicity Grade 3 or 4(Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012))
- Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters(Up to 50 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter StatusCTRI/2009/091/000827Merck KGaA504
已完成
2 期
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter StatusGlioblastomaNCT00813943EMD Serono265
进行中（未招募）
不适用
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). - NDEWLY DIAGNOSED, HISTOLOGICALLY PROVEN GBM WITH PROVEN METHYLATED MGMT GENE PROMOTER STATUSMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiformeEUCTR2007-004344-78-ITMERCK KGAA1,400
终止
1 期
Cilengitide Imaging Trial in GlioblastomaSupratentorial Newly Diagnosed Inoperable GliobastomaNCT01558687Merck KGaA, Darmstadt, Germany1
终止
2 期
Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)GliosarcomaGlioblastoma MultiformeNCT01186406Duke University41