Drug level and Investigation of Novel Substances Indicated Downstream Effect in (INSIDE) glioblastoma - INSIDE

Sahlgrenska University Hospital0 个研究点目标入组 40 人开始时间: 2017年1月11日最近更新: 2020年9月21日

适应症

试验速览

暂无简介。

•1. A suspected glioblastoma (based on MRI) or recurrent glioblastoma undergoing surgical resection.
•2. Elective surgical indication.
•3. Age 18 years or older.
•4. Karnofsky performance status of 60 – 100.
•5. Not receiving another experimental treatment for glioblastoma at the moment of inclusion.
•6. Able to take oral medications.
•7. No known allergy to substance.
•8. Absolute neutrophil count = 1,500/mcL and platelets = 100,000/mcL.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. Other likely diagnosis than glioblastoma based on MRI.
•2. Pregnant and/or breastfeeding.
•3. Women of childbearing potential who do not have a negative pregnancy test (not older than 14 days) before inclusion.
•4. History of active liver disease, including chronic active hepatitis, viral hepatitis (hepatitis B, C and CMV), cholestatic jaundice of any etiology or toxic hepatitis or inadequate hepatic function, defined as baseline ASAT and ALAT > 1.5 X upper institutional limit and/or bilirubin > 1.5 X upper institutional limit.
•5. Suspected significant raised intracranial pressure or other indication for emergent surgery.
•6. Unfit for participation for any other reason judged by the including physician.
•7. Unfit for participation due to any substance specific contraindications

发起方

Sahlgrenska University Hospital