Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02364206 : Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: 75 Years
Eligibility
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- Have previously completed or withdrawn from this study or any other study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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02364206      |      Link to official Clinicaltrials.gov listing
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