drugset / Trial / NCT04391595
LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients
Phase 0
Completed
42 enrolled
Nader Sanai
Barrow Neurological Institute · collabEli Lilly and Company · collabIvy Brain Tumor Center · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2020-07-11
- Primary completion
- 2023-07-27
- Completion
- 2025-09-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 100 mg | — |
| Subject | TEMUTERKIB | Small molecule | 400 mg | — |