NCT00093964已完成2 期
A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects With Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of Cilengitide (EMD 121,974) Administered as a Single Agent.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 81
- 试验地点
- 17
- 主要终点
- Percentage of Subjects With Progression-free Survival
研究概览
简要总结
This study will investigate clinical activity, safety, and tolerability of the anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of glioblastoma multiforme (GBM).
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
- •Written informed consent obtained before undergoing any study-related activities.
- •Males or females 18 years of age or older who can be treated in an outpatient setting.
- •Histologically proven GBM, which is recurrent or progressive following surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy (Gliadel wafer therapy is not considered systemic chemotherapy). Malignancy is to be documented with a previous histopathological report.
- •Subjects initially diagnosed with other conditions similar to GBM (such as anaplastic astrocytoma [AA] or low grade glioma) that subsequently progressed to histologically proven GBM and have had surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy for the original diagnosis are eligible if they meet all inclusion criteria.
- •GBM recurring only in the contralateral hemisphere must be histologically confirmed by biopsy. GBM recurring bilaterally does not need to be histologically confirmed by biopsy (i.e., if recurrence is ipsilateral and contralateral).
- •Archived tumor tissue specimens from the GBM surgery or biopsy must be available for central pathology review and exploratory analysis of angiogenic markers (e.g. αvβ3 and αvβ5 integrins).
- •Measurable disease (solid contrast-enhancing lesion greater than or equal to (>=)1 cm in any dimension) evaluated by gadolinium-enhanced magnetic resonance imaging (Gd MRI) within 2 weeks prior to the first dose of EMD
- •At least 12 weeks have elapsed since the last radiation treatment, and at least 4 weeks have elapsed since the last chemotherapy dose (at least 6 weeks for nitrosourea-containing chemotherapy) prior to the first dose of EMD
- •If the subject underwent recent surgery, status must be >=2 weeks post surgery or >=1 week post biopsy, in stable condition, and maintained on a stable corticosteroid regimen for >=5 days prior to first dose of EMD
- •Karnofsky Performance Score (KPS) of >=70%.
- •Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable methods of birth control to avoid conception during the study and for at least 6 months after receiving the last dose of study drug.
- •Women of childbearing potential must have a negative pregnancy test at screening.
- •Laboratory values (within 1 week prior to the first dose of EMD 121974, except for blood count and Prothrombin time (PT)/Partial thromboplastin time (PTT), which are to be within 72 hours of the first dose): Absolute neutrophil count >=1500/millimeter (mm)^
- •Platelets >=100,000/mm^
- •Creatinine less than or equal to (<=) 1.5 milligram/deciliter (mg/dL) or creatinine clearance >=60 mL/min. Hematocrit >=30%. Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits. Hemoglobin >=10 mg/dL. Total bilirubin <=1.5 times the upper limit of normal. Aspartate aminotransferase and alanine aminotransferase <=2.5 times above upper limit of normal.
- •No more than 8 weeks have elapsed since recurrence was detected
排除标准
- •Prior radiation therapy greater than (>) 66 Gray.
- •Subject anticipates undergoing elective surgery, dental extraction, or invasive dental procedures.
- •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 EMD
- •Prior antiangiogenic therapy.
- •Placement of Gliadel wafer at surgery for recurrence.
- •Unable to undergo Gd MRI.
- •Current known alcohol dependence or drug abuse.
- •Requiring concomitant chemotherapy.
- •Treatment with a prohibited concomitant medication.
- •Known hypersensitivity to the study treatment.
- •Legal incapacity or limited legal capacity.
研究组 & 干预措施
Cilengitide 500 Milligram (mg)
Experimental
干预措施: Cilengitide 500 mg (Drug)
Cilengitide 2000 mg
Experimental
干预措施: Cilengitide 2000 mg (Drug)
结局指标
主要结局
Percentage of Subjects With Progression-free Survival
时间窗: Month 6
Progression-free survival was defined as subjects who survived greater than or equal to (\>=) 180 days without disease progression. Disease progression was assessed as per independent central blinded radiology assessment.
次要结局
- Percentage of Subjects With Overall Response Rate(From the start of treatment up to 6 years)
- Time to Disease Progression(From the start of treatment until disease progression (assessed up to a maximum of 6 years))
- Overall Survival Time(From the start of treatment until death (assessed up to a maximum of 6 years))
- Percentage of Subjects With 1-year of Survival Rate(From the start of treatment up to 1 year)
- Maximum Observed Plasma Concentration (Cmax)(Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2)
- Time to Reach Maximum Plasma Concentration (Tmax)(Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2)
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Administration (AUC 0-infinity)(Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2)
- Apparent Terminal Rate Constant (Lambda z)(Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2)
- Terminal Half-life (t1/2)(Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2)
- Mean Residence Time of Drug in the Body (MRT)(Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2)
- Total Body Clearance (CL) of Drug From Plasma/Cerebro Spinal Fluid (CSF)(Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2)
- Apparent Volume of Distribution During the Terminal Phase (Vz)(Pre-dose,1,1.5,2,3,4,8 and 24 hours post-infusion on Day 1 of Week 1 in Cycles 1 and 2)
- Apparent Volume of Distribution at Steady State (Vss)(Pre-dose, 1, 1.5, 2, 3, 4, 8, 24 hours post-infusion on Day 1 of Week 1 in Cycle 1 and 2)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the start of treatment up to 6 years)
研究者
研究点 (17)
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