Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT02364206
Eligibility Criteria:
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* Have previously completed or withdrawn from this study or any other study investigating LY2228820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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02364206
Study Brief:
Protocol Section:
NCT02364206