EUCTR2018-004064-62-DE进行中（未招募）1 期
Single-arm, dose-escalation Phase 1/2 Study of olaptesed pegol (NOX-A12) in combination with irradiation in inoperable or partially resected first-line glioblastoma patients with unmethylated MGMT promoter with a 3-arm expansion group including fully resected patients and combination with bevacizumab or pembrolizumab - GLORIA
OXXON Pharma AG0 个研究点目标入组 27 人开始时间: 2019年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
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
- •Criteria for inclusion - Dose escalation cohorts:
- •1. Written informed consent
- •2. Age =18 years
- •3. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy (e.g., MGMT promotor analysis, cytogenetic markers such as IDH-1 mutations, etc.)
- •4. Patient agrees to subcutaneous port implantation
- •5. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
- •6. Status post biopsy or incomplete resection (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan)
- •7. Unmethylated MGMT promoter status
- •8. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
- •9. Estimated minimum life expectancy 3 months
- •10. Stable or decreasing dose of corticosteroids during the week prior to inclusion
- •11. The following laboratory parameters should be within the ranges specified:
- •Total bilirubin = 1.5 x upper limit normal (ULN)
- •Creatinine = 1.5 x ULN or glomerular filtration rate = 60 mL/min/1.73m²
- •ALT (alanine transaminase) = 3 x ULN
- •AST (aspartate transaminase) = 3 x ULN
- •12. Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
- •13. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP
- •Criteria for inclusion - Expansion Group:
- •1. Written informed consent
- •2. Age = 18 years
- •3. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy (e.g., MGMT promoter analysis, cytogenetic markers such as IDH-1 mutations, etc.)
- •4. Patient agrees to subcutaneous port implantation
- •5. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
- •6. a) Status post biopsy or incomplete resection (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan) or complete resection (Arm A)
- •b) Status post complete resection (Arm B)
- •c) Status post complete or incomplete resection (circumscribed enhancing tumor = 5.0 cm in largest diameter as per postoperative T1-weighted, contrast-enhanced MRI scan) (Arm C)
- •7. Unmethylated MGMT promoter status
- •8. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
- •9. Estimated minimum life expectancy 3 months
- •10. Stable or decreasing dose of corticosteroids during the week prior to inclusion
- •11. The following laboratory parameters should be within the ranges specified:
- •Total bilirubin = 1.5 x upper limit normal (ULN)
- •Creatinine = 1.5 x ULN or glomerular filtration rate = 60 mL/min/1.73m²
- •ALT (alanine transaminase) = 3 x ULN
- •AST (aspartate transaminase) = 3 x ULN
- •12. Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 3 months (6 months Arm A, 4 months Arm C) following last dose of dr
排除标准
- •All patients
- •Cytostatic therapy (chemotherapy) within the past 5 years
- •History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years)
- •Prior radiotherapy to the head
- •Any other previous or concomitant experimental glioblastoma treatments
- •Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) = 200 mg/dL (7.0 mmol/L), or HbA1c = 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations
- •Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
- •Dose Escalation Cohorts
- •Clinically significant or uncontrolled cardiovascular disease, including, Myocardial infarction in the previous 12 months, Uncontrolled angina, Congestive heart failure (New York Heart Association functional classification of =2), Diagnosed or suspected congenital long QT syndrome, QTc prolongation on an electrocardiogram prior to entry (>470 ms), Uncontrolled hypertension (blood pressure = 160/95 mmHg), Heart rate <50/min on the baseline electrocardiogram, History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)
- •Arms A and B
- •Planned hypofractionated radiotherapy
- •Secondary malignancy which is currently active
- •Clinically significant or uncontrolled cardiovascular disease, including Myocardial infarction in the previous 12 months, Uncontrolled angina, Congestive heart failure (New York Heart Association functional classification of =2), Diagnosed or suspected congenital long QT syndrome, QTc prolongation on an electrocardiogram prior to entry (>470 ms), Uncontrolled hypertension (blood pressure = 160/95 mmHg), Heart rate <50/min on the baseline electrocardiogram, History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes), Cerebrovascular accident
- •Patients with a history of arterial or venous thrombosis (or any other disease) requiring permanent intake of anticoagulants (Arm A only)
- •Prolongation of coagulation factors = 2.5 x ULN (Arm A only)
- •Biopsy-only of GBM with less than 20% of tumor removed
- •Presence of extracranial metastatic or leptomeningeal disease
- •Severe hypersensitivity (= Grade 3) to other monoclonal antibodies
- •Receiving immunosuppressive therapy
- •Previous or current treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PDL2 agent
- •Planned hypofractionated radiotherapy
- •Clinically significant or uncontrolled cardiovascular disease, including Myocardial infarction in the previous 12 months, Uncontrolled angina, Congestive heart failure (New York Heart Association functional classification of =2), Diagnosed or suspected congenital long QT syndrome, QTc prolongation on an electrocardiogram prior to entry (>470 ms
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