NCT03603379已完成1 期
A Pharmacokinetic Phase 1 Study of Anti-epidermal Growth Factor Receptor (EGFR) -Immunoliposomes Loaded With Doxorubicin in Patients With Relapsed or Refractory High-grade Gliomas
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年11月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Ratio of C225-ILs-dox concentration
研究概览
简要总结
Anti-EGFR-immunoliposomes loaded with doxorubicin (C225-ILs-dox) are given intravenously in patients with relapsed or refractory high-grade gliomas.
The pharmacokinetics of C225-ILs-dox in peripheral blood (PB), cerebro-spinal fluid (CSF) and resected tumour tissue will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 according to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures
- •Patients with relapsed histologically proven glioblastoma ≥ 18 years of age.
- •Patients need to have at least one line of treatment with combined radio-chemotherapy
- •EGFR amplification. EGFR amplification will be tested by comparative genomic hybridization (CGH) method. EGFR will be considered amplified if the value is 0.15 above the average signal of chromosome
- •Evaluable disease on MRI brain scan
- •Adequate bone marrow function: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
- •Adequate hepatic function: bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST), Alanin-Aminotransferase (ALT) and alkaline phosphatase (AP) ≤ 2.5 x ULN
- •Adequate renal function: serum creatinine ≤ 1.5 x ULN and calculated creatinine clearance > 30 mL/min, according to the formula of Cockcroft-Gault
- •Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by either echocardiography (ECHO) or radionuclide angiocardiography (MUGA) in addition to pre- (brain-type natriuretic Peptide) BNP from peripheral blood
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours).
- •No contraindications for lumbar puncture
- •Women with child-bearing potential have to use effective contraception, are not allowed to be pregnant and have to agree not to become pregnant during trial treatment and during the 6 months thereafter. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential.
排除标准
- •History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration except for adequately treated cervical carcinoma in situ and localized non-melanoma skin cancer.
- •Lack to provide written informed consent
- •Previous therapy with more than 240 mg/m2 of doxorubicin or more than 450 mg/m2 of epirubicin
- •Any serious underlying medical condition (at the judgement of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, etc.)
- •Breastfeeding and pregnancy
- •Participation in any investigational drug trial within 4 weeks preceding treatment start
- •Any concomitant drugs contraindicated when administering Erbitux™ or Caelyx™ according to the Swissmedic-approved product information
- •Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
- •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
研究组 & 干预措施
C225-ILs-dox i.v.
Experimental
C225-ILs-dox administered intravenously
干预措施: C225-ILs-dox (Drug)
结局指标
主要结局
Ratio of C225-ILs-dox concentration
时间窗: 24 hours after first C225-ILs-dox application
Ratio of C225-ILs-dox concentration in cerebro-spinal fluid over the C225-ILs-dox concentration in peripheral blood.
次要结局
- Toxicity as graded by the CTCAE Version 4.0(12 months)
- Best achieved tumour response (1st or second MRI scan) during treatment phase according to RANO criteria ((between day 28 and day 104)
- Event free survival(12 months)
- Progression free survival(12 months)
- Tumour response according to RANO criteria on the final MRI scan(At the end of 4 treatment cycle 4 (each cycle is 28 days))
- Overall survival(12 months)
研究者
研究点 (2)
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