EUCTR2008-001078-34-NL进行中（未招募）1 期
Phase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with radiotherapy and concomitant and adjuvant temozolomide
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
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
- •Histological confirmed glioblastoma multiforme at primary diagnosis
- •Tumours which do enhance on pre-operative imaging
- •Age >=18-65
- •WHO performance status 0-2, RTOG- RPA class III-IV.
- •No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- •Willing and able to comply with the study prescriptions
- •Have given written informed consent before patient registration
- •Patient able to tolerate full course of radiotherapy
- •No previous radiotherapy to the head and neck area.
- •Prior neurosurgery within 6 weeks of treatment
- •No previous irradiation of the brain.
- •No previous chemotherapy
- •No prior or concurrent medical condition which would make treatment difficult to complete. Medication with steroids is allowed (See concomitant treatment chapter).
- •No uncontrolled infectious disease
- •No use of terfenadine, astemizol, cisapride, sildenafil, lovastatin or simvastatin
- •No concurrent medication that is metabolized by the CYP3A4 isoenzyme and cannot be replaced with other equivalent medications for the period of the study: antiarrhythmics (amiodarone, quinidine), neuroleptics (pimozide), sedative/hypnotic agents (midazolam, triazolam), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), HMG-CoA reductase inhibitors (lovastatin, simvastatin, atorvastatin), rifampin, rifabutin, felodipine, nifedipine, and sildenafil or St. John's wort.
- •Adequate haematological, renal and hepatic function
- •Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
- •Absence of any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
- •All patients of reproductive potential (male and female) must use effective contraception for the whole duration of the treatment and until 6 months thereafter. Females must not be pregnant or lactating
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •the opposite of the above
研究者
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