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2019年2月8日

适应症glioblastoma MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: glioblastoma
发起方: OXXON Pharma AG
入组人数: 27
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2019年2月8日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

OXXON Pharma AG

入排标准

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

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)