Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening

Exclusion Criteria16

• Current participation in another therapeutic clinical trial
• Patients with a concurrent malignancy or malignancy within five years prior of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years
• Pregnant or lactating women
• Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody \[HBsAg\] test and a positive anti-hepatitis B core antibody \[HBcAb\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
• Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells/mm3 , no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
• Any of the following co-morbidities:
• Pre-existing severe peripheral neuropathy (\> CTCAE grade 2)
• Hepatic impairment (Bilirubin Level \>1.5x-3x ULN)
• Kidney dysfunction (CrCl \< 59 mL/min)
• Cardiac dysfunction with left ventricular ejection fraction \<60 %
• Any grade of interstitial lung disease
• Ongoing or previous history of rhabdomyolysis
• Acute pancreatitis
• QTcF ≥480 msec
• Diabetes mellitus with fasting glucose \> 250mg/dl or 13.9 mmol/L
• Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.