NL-OMON32210招募中不适用
Phase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with concomitant temozolomide and radiotherapy. - Phase I/II study with nelfinavir and radiochemotherapy for glioblastoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histological confirmed glioblastoma multiforme at primary diagnosis
- •Tumours which do enhance on pre-operative imaging
- •Age >=18-70
- •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
- •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
排除标准
- •the opposite of the above
研究者
相似试验
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 temozolomidePhase I/II study for patients with newly diagnosed glioblastoma testing nelfinavir in combination with radiotherapy and concomitant and adjuvant temozolomideMedDRA version: 9.1Level: LLTClassification code 10018336Term: GlioblastomaMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiformeEUCTR2008-001078-34-NLMaastro Clinic57
已完成
2 期
A Phase II study in adult patients with newly-diagnosed chronic myeloid leukaemia of initial intensified Glivec® therapy, and sequential combination therapy for non-responders. With Protocol Amendments October 2004: to include an Extension Phase of the StudyACTRN12607000614493Australasian Leukaemia and Lymphoma Group103
已完成
2 期
A phase II, multicenter, study for newly diagnosed glioblastomas using boron neutron capture therapy, additional X-ray treatment and chemotherapyewly-diagnosed glioblastomaJPRN-UMIN000002385Dept. of Neurosurgery, Osaka Medical College45
进行中（未招募）
不适用
A phase II study for the treatment of patients with splenic marginal lymphoma with the combination of Cyclophosfamide, Vincristine, Liposomal Doxorubicin, Predinisone and RituximabTreatment of patients with newly diagnosed splenic marginal non Hodgkin lymphomaMedDRA version: 9.1Level: LLTClassification code 10062113Term: Splenic marginal zone lymphomaEUCTR2005-000693-45-ITG.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
进行中（未招募）
1 期
Study of safety and efficacy of genome-edited hematopoietic stem and progenitor cells in sickle cell disease (SCD)EUCTR2019-003489-41-ITOVARTIS PHARMA AG30