Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma

Inclusion criteria

• Newly diagnosed and histologically confirmed glioblastoma
• Recursive partitioning analysis (RPA) class III or IV
• Age > or = 18 years and < 75 years of age
• Life expectancy > or = 6 months
• Patient must have at least 1 formalin fixed paraffin embedded tumor tissue block representative of glioblastoma available for pathology central review and biomarker exploration
• Adequate hematologic (absolute neutrophil count (ANC) > or = 1.5 x 109/L, platelet count > or = 100 x 109/L, hemoglobin > or = 10 g/dL ), renal (creatinine > or = 1.25 x ULN ), and hepatic function (total bilirubin < or = 1.5 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN)
• Patients who were receiving corticosteroids had to receive a stable or decreasing dose for at least 14 days before enrollment
• Patients must be able to swallow and retain oral medication
• Women must have a negative serum pregnancy test less than 7 days prior to the first dose of study drug
• Both men and women of reproductive potential agree to use approved contraception during the study and for 6 months after discontinuation of study treatment.
• Willing and able to comply with the protocol as judged by the investigator
• Patients must provide written consent

Exclusion criteria

• Any prior chemotherapy (including carmustine-containing wafers) or immunotherapy (including vaccine therapy )
• Any prior radiotherapy to the brain
• Any contraindication to temozolomide listed in the local label
• Have had, in the judgment of the investigator, a major bowel resection that would alter oral drug absorption
• Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Have previously completed or withdrawn from this study or any other study investigating LY2228820
• Are receiving, in the judgment of the investigator, concurrent administration of immunosuppressive therapy
• Diarrhea of any cause CTCAE > or = grade 2
• Current or recent (within 30 days of enrollment) treatment with another investigational drug or participation in another investigational study
• History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
• Pregnant or nursing (lactating) woman, or fertile women unwilling or unable to use effective means of contraception
• Psychiatric illness / social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance / pill diary