This is a study of oral LY2157299 as monotherapy and in combination with lomustine in participants with recurrent malignant glioma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baltimore, Maryland, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Recommended Dose for Phase 2 Studies
Time frame: Time of first dose to time of last dose (estimated up to 8 years)
Number of Participants with Tumor Response
Time frame: Time of first dose to time of last dose (estimated up to 8 years)
Biologically Effective Dose Range
Time frame: Baseline, Days 1, 12, 13 of Cycle 1, Days 1 and 12 of Cycle 2 of Part A - LY2157299 as monotherapy
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC)
Time frame: Part A Cycle 1: predose, up to 6 hours on Days 1, 3, 6, 12, 13, and 14; Part A Cycle 2: predose up to 6 hours on Days 1, 12, and 13. Part B Cycle 1: predose up to 6 hours on Days 1, 6, 7, 10, 12, 13, and 14
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Time frame: Part A Cycle 1: predose, up to 6 hours on Days 1, 3, 6, 12, 13, and 14; Part A Cycle 2: predose up to 6 hours on Days 1, 12, and 13. Part B Cycle 1: predose up to 6 hours on Days 1, 6, 7, 10, 12, 13, and 14
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Madrid, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seville, Spain