NCT05977738已完成早期 1 期
Phase 0 lead-in Trial of Pitavastatin in Primary and Recurrent Glioblastoma Patients
C.Dirven1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年1月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Intratumoral pitavastatin concentration as assessed by LC-MS analysis on tumour tissue.
研究概览
简要总结
The goal of this Phase 0 trial is to study if pre-operative oral pitavastatin administration reaches the tumour in patients with primary or a recurrent glioblastoma. The main question[s] it aims to answer are:
- Does pitavastatin reach a cytotoxic concentration in gadolinium-enhanced tumour tissue after oral administration?
- Does pitavastatin achieve a concentration that can synergize with temozolomide in the gadolinium non-enhanced area of the tumour?
Participants will receive pitavastatin in differing dosages a week before their elective surgery and blood and tumour samples will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Eligible for resection of a suspected primary glioblastoma or a recurrent glioblastoma.
- •MRI- measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 1 perpendicular measurement of at least 0.5 cm.
- •Adequate Renal Function defined as: estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 by Chronic Disease Epidemiology Collaboration (CKD-EPI) equation.
- •CK elevation 3 X ULN.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Participant has voluntarily agreed to participate by giving written informed consent Written informed consent for participation in the protocol must be obtained prior to any screening procedures taking place.
- •Willingness and ability to comply with all scheduled visits, treatment plans, laboratory tests and other procedures.
- •Age ≥18 years at time of consent.
- •Ability and willingness to swallow oral medication.
- •Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.
- •For females of reproductive potential: use of highly effective contraception method defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly.
- •Females of child-bearing potential must agree not to breastfeed starting at screening, and throughout the study period.
排除标准
- •Pregnancy or lactation.
- •Known allergic reactions to components of the pitavastatin calcium tablets.
- •Patients with ALAT and ASAT levels 3 X ULN.
- •Unwillingness to temporarily stop an already prescribed statin, during treatment with pitavastatin.
- •Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy.
- •Concomitant use of cyclosporin, gemfibrozil, systemic fusidic acid, fibrates, niacin or colchicine.
- •Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, unexplained elevated liver transaminase levels, and active and chronic hepatitis as determined by the investigator.
- •Suspicion of oral malabsorption, influencing the uptake of drugs from the ileum, such as Morbus Crohn.
- •Treatment with another investigational drug or other intervention within 30 days prior to enrolment or within 5 half-lives of the investigational product, whichever is longer.
研究组 & 干预措施
Dose group 1: 16 mg
Experimental
Pitavastatin 16 mg via oral route in the form of daily tablets for 6 days before SOC surgery
干预措施: Pitavastatin calcium (Drug)
Dose group 2: 32 mg
Experimental
Pitavastatin 32 mg via oral route in the form of daily tablets for 6 days before SOC surgery
干预措施: Pitavastatin calcium (Drug)
Dose group 3: 48 mg
Experimental
Pitavastatin 48 mg via oral route in the form of daily tablets for 6 days before SOC surgery
干预措施: Pitavastatin calcium (Drug)
结局指标
主要结局
Intratumoral pitavastatin concentration as assessed by LC-MS analysis on tumour tissue.
时间窗: From the last patient visit of each dose cohort at day 9 to 2 weeks after the last patient visit of each dose cohort.
Detection of pitavastatin in gadolinium enhanced and gadolinium non-enhanced tumour. tissue in relation to serum levels after preoperative administration.
次要结局
- Tolerability of short-term pitavastatin treatment as assesseb by a customized questionnaire related to adverse events found during the use of pitavastatin.(From the last patient visit of the last dose cohort to 2 weeks after the last patient visit of the last dose cohort on day 9.)
- Relation of plasma pitavastatin concentration and intratumoral pitavastatin concentration as assessed by LC-MS analysis on plasma and tumour tissue.(From the moment the LC-MS analysis of the last patient tumour tissue and plasma is performed to two weeks after the last patient visit on day 9 of the last dose cohort.)
研究者
C.Dirven
Prof. dr.
Erasmus Medical Center
研究点 (1)
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