Spots Global Cancer Trial Database for LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients
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Trial Identification
Brief Title: LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients
Official Title: A Phase 0/2 Study of LY3214996 (ERK Inhibitor) in Combination With Abemaciclib (CDK4 and 6 Inhibitor) in Recurrent Glioblastoma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration
Study ID: NCT04391595
Study Description
Brief Summary: This trial is an open-label, multicenter, Phase 0/2 trial that will enroll up to 50 participants with recurrent glioblastoma which are schedule for resection. In the lead-in cohort, a total of 10 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered LY3214996 plus Abemaciclib prior to surgical resection of their tumor. If positive PK results are demonstrated in ≥50% of Phase 0 participants and at least 5 participants are enrolled into Phase 2, up to approximately 40 additional participants will be enrolled in the dose expansion cohort in order to achieve a total of 25 participants enrolled into Phase 2 (lead-in cohort + dose expansion).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chandler Regional Medical Center, Chandler, Arizona, United States
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
HonorHealth Scottsdale Osborn Medical Center, Scottsdale, Arizona, United States
Contact Details
Name: Nader Sanai, MD
Affiliation: Deputy Director of the Ivy Brain Tumor Center
Role: PRINCIPAL_INVESTIGATOR
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