Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05567679
Status:
WITHDRAWN
Last Update Posted:
2023-09-22
First Post:
2022-09-28
Brief Title:
A Study of Tazemetostat Tazverik Before Prostatectomy in Men With Prostate Cancer
Sponsor:
Edwin Posadas MD
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
IIT2021-09-Posadas-NA-TAZ A Study of Tazemetostat Tazverik Before Prostatectomy in Men With Prostate Cancer
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI voluntarily closed the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open-label single-arm pilot perioperative study of EZH2 inhibition in patients undergoing Radical Prostatectomy RP The EZH2 inhibition is intended to increase the sensitivity of the underlying tumor to the patients immune system
Given the absence of data in this setting we propose to pilot this experience with 4 weeks of tazemetostat at doses known to be clinically safe and effective at inducing clinical effects via inhibition of EZH2 as established for follicular lymphoma and epithelioid sarcoma 800 mg twice daily with or without food
Prior to tazemetostat blood will be collected 4 tubes for immune cells Circulating Tumor Cells and plasma This will be repeated at the time of RP RP tissues will be collected
Additionally patients will have a week lead-in to wear a FitBit Charge 5TM device or similar model to continuously monitor physical activity from baseline up until end of study The start of the week lead-in will be considered the baseline visit Subjects will also be asked to continue wearing the device until end of study and option to continue for up to 2 years after end of study in follow-up
Given the absence of data in this setting we propose to pilot this experience with 4 weeks of tazemetostat at doses known to be clinically safe and effective at inducing clinical effects via inhibition of EZH2 as established for follicular lymphoma and epithelioid sarcoma 800 mg twice daily with or without food
Prior to tazemetostat blood will be collected 4 tubes for immune cells Circulating Tumor Cells and plasma This will be repeated at the time of RP RP tissues will be collected
Additionally patients will have a week lead-in to wear a FitBit Charge 5TM device or similar model to continuously monitor physical activity from baseline up until end of study The start of the week lead-in will be considered the baseline visit Subjects will also be asked to continue wearing the device until end of study and option to continue for up to 2 years after end of study in follow-up
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?:
True
Is an FDA AA801 Violation?:
None