The purpose of this trial is to show proof of concept that by blocking the Transforming Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical benefit. Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health Organization Grade III and IV). Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299 in combination with standard radiochemotherapy in patients with newly diagnosed glioblastoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Administered orally
Administered as approved
Administered orally
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.
La Jolla, California, 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.
San Francisco, California, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
Phase 1: Recommended dose for Phase 2 portion
Time frame: Baseline to phase 1 completion
Phase 2: Relationship of change in response biomarker to clinical benefit
Time frame: Baseline through discontinuation from any cause
Phase 1: Pharmacokinetics - Concentration Maximum
Time frame: Baseline, prior to first dose of cycle 1 and 2 and on days 1, 3, 8, 14, 15 and 16
Phase 1: Number of patients with a tumor response
Time frame: Baseline to Progressive Disease
Phase 2: Overall Survival at 12 Months
Time frame: Randomization to date of death from any cause at 12 months
Phase 2: Overall Survival
Time frame: Randomization to date of death from any cause
Phase 2: Progression Free Survival
Time frame: Randomization to measured progressive disease or death from any cause
Phase 2: Proportion of patients achieving an objective response (Response Rate)
Time frame: Randomization to measured progressive disease
Phase 2: Duration of tumor Response
Time frame: Time of response to measured progressive disease or death from any cause
Phase 2: Time to Treatment Failure
Time frame: Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause
Phase 1: Pharmacokinetics - Time to Concentration Maximum
Time frame: Baseline, prior to first dose of cycle 1 and 2 and on days 1, 3, 8, 14, 15 and 16
Phase 1: Pharmacokinetics - Area under the Curve
Time frame: Days 12 to 14 in cycle 1 and in cycle 3
Phase 2: Change from baseline in MD Anderson Symptom Inventory - Brain Tumor
Time frame: Baseline, 30 day post study day follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Indianapolis, Indiana, 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.
Durham, North Carolina, United States
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Frankfurt, Germany
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Heidelberg, Germany
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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.
Madrid, Spain