Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05940493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-07-04
Brief Title:
Abemaciclib in Newly Diagnosed Meningioma Patients
Sponsor:
Nader Sanai
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
A Phase 2 Multicenter Double-blind Randomized-controlled Study of Abemaciclib CDK4 and 6 Inhibitor in Newly Diagnosed RB-proficient Grade 3 Meningioma Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to learn about how an investigational drug called abemaciclib works in treating patients with a newly-diagnosed grade 3 meningioma Abemaciclib is a drug that is approved by the FDA but not for brain tumors
Participants who consent to the trial will have surgical tissue collected from the planned surgical resection and tested If the tissue shows positive results for RB cells and participants are qualified they will be enrolled and receive study treatment two to five weeks after completing standard-of-care radiation therapy
This is a randomized clinical trial which means that participants will be randomly assigned to a treatment based on chance like a flip of a coin Neither the participant nor the researcher chooses the assigned group Randomization will help the researchers study how the drug works by comparing the difference between the study drug and the placebo and how they work in treating brain tumors This is a double-blinded study which means that neither the participant nor the study team will know which treatment the participant is receiving
Participants who consent to the trial will have surgical tissue collected from the planned surgical resection and tested If the tissue shows positive results for RB cells and participants are qualified they will be enrolled and receive study treatment two to five weeks after completing standard-of-care radiation therapy
This is a randomized clinical trial which means that participants will be randomly assigned to a treatment based on chance like a flip of a coin Neither the participant nor the researcher chooses the assigned group Randomization will help the researchers study how the drug works by comparing the difference between the study drug and the placebo and how they work in treating brain tumors This is a double-blinded study which means that neither the participant nor the study team will know which treatment the participant is receiving
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-500-352-34-38 | OTHER | St Josephs Hospital | None |