EUCTR2008-004457-15-AT进行中（未招募）不适用
Cilengitide in subjects with newly diagnosed glioblastoma multiforme and unmethylated MGMT gene promoter - a multicenter, open-label Phase II study, investigating two cilengitide regimens in combination with standard treatment (temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy) - CORE. - CORE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent obtained before undergoing any study-related activities.
- •2. Newly diagnosed histologically proven supratentorial GBM (World Health Organization [WHO] Grade IV, including GBM subtypes, e.g. gliosarcoma). The histological diagnosis must be obtained from a neurosurgical resection of the tumor or by an open biopsy (stereotactic biopsy not allowed).
- •3. Tumor tissue specimens from the GBM surgery or open biopsy (formalin-fixed paraffin-embedded [FFPE] block) must be available for MGMT gene promoter status analysis and central pathology review.
- •4. Proven unmethylated MGMT gene promoter status (i.e. cut-off ratio <2 by means of applied test to determine MGMT gene promoter status)
- •5. Males or females =18 years of age.
- •6. Interval of =2 weeks but =7 weeks after surgery or biopsy before first administration of study treatment.
- •7. Available post-operative Gd-MRI performed within <48 hours after surgery (in case that it was not possible to obtain a Gd-MRI within <48 hours post surgery, a Gd-MRI is to be performed prior to randomization).
- •8. Stable or decreasing dose of steroids for =5 days prior to randomization.
- •9. ECOG PS of 0-1.
- •10. 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, 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).
- •11. Laboratory values (within 2 week prior to randomization):
- •Absolute neutrophil count =1500/mm3.
- •Platelets =100,000/mm3.
- •Creatinine =1.5 x upper limit of normal (ULN) or creatinine clearance rate =60 mL/min.
- •Prothrombin time (PT) international normalized ratio (INR) within normal limits and partial thromboplastin time (PTT) below upper limit of normal.
- •Hemoglobin =10 g/dL.
- •Total bilirubin =1.5 x the ULN.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x ULN (except when attributable to anticonvulsants) or transient increase post surgery attributable to narcotics).
- •Alkaline phosphatase =2.5 x ULN.
- •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
排除标准
- •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. Planned major surgery for other diseases
- •7. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
- •8. 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.
- •9. History of coagulation disorder associated with bleeding or recurrent thrombotic events.
- •10. Clinically manifest myocardial insufficiency (New York Heart Association [NYHA] III, IV) or history of myocardial infarction during the past 6 months; or uncontrolled arterial hypertension.
- •11. Inability to undergo Gd-MRI.
- •12. Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
- •13. Subject is pregnant (positive serum beta human chorionic gonadotropin [b-HCG] test at screening) or is currently breast-feeding, or has the potential and anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessar, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment.
- •14. Current alcohol dependence or drug abuse.
- •15. Known hypersensitivity to the study treatment.
- •16. Legal incapacity or limited legal capacity.
- •17. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
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