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NCT04391595 · ClinicalTrials.gov registry record · Early Phase 1
LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients
A Early Phase 1 study, sponsored by Nader Sanai.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 42
- Enrollment target
NCT04391595: Completed Early Phase 1 study, sponsored by Nader Sanai.
NCT04391595 is a Early Phase 1 study that has completed, run by Nader Sanai. The registered enrollment target is 42 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04391595, a Early Phase 1 study, has completed, sponsored by Nader Sanai.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 42 participants
- Enrollment target
Study 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).
Primary Outcome
Total and Unbound LY3214996 and Abemaciclib (and related M2 and M20 metabolites) concentration in enhancing and non-enhancing tumor tissue
Interventions
- DRUG Abemaciclib
- DRUG LY3214996
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-07-11 |
| Est. Completion | 2025-09-03 |
| Phase | Early Phase 1 |
What the finished NCT04391595 record still lists
NCT04391595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Abemaciclib is the first listed.
NCT04391595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04391595 about?
NCT04391595 is a clinical study titled "LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients". 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 administere...
What is the current status of trial NCT04391595?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 42 participants. The study started on 2020-07-11. Estimated completion is 2025-09-03.
What interventions are being tested in trial NCT04391595?
The interventions under investigation include: Abemaciclib (DRUG), LY3214996 (DRUG).
Who is sponsoring clinical trial NCT04391595?
This trial is sponsored by Nader Sanai, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04391595's enrollment target sits among peer trials
42 605th of 2000 higher than 1,379 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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