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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 is a Early Phase 1 study that has completed, run by Nader Sanai. The registered enrollment target is 42 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04391595
The ClinicalTrials.gov registry entry for NCT04391595 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nader Sanai, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Abemaciclib is the first listed.
NCT04391595 reports 0 study locations.
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.
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