Ignite Creation Date:
2024-05-06 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03480646
Status:
UNKNOWN
Last Update Posted:
2021-07-26
First Post:
2018-03-07
Brief Title:
ProSTAR A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer
Sponsor:
Constellation Pharmaceuticals
Organization:
Constellation Pharmaceuticals
Study Overview
Official Title:
A Phase 1b2 Study of CPI-1205 a Small Molecule Inhibitor of EZH2 Combined With Enzalutamide or AbirateronePrednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a two-arm open label Phase 1b2 study with an oral administration of CPI-1205 in combination with either enzalutamide or abirateroneprednisone in male patients with metastatic Castration Resistant Prostate Cancer This study is designed to determine the maximum tolerated dose MTD and recommended Phase II dose RP2D based on safety tolerability pharmacokinetic and efficacy profiles of CPI-1205 in combination with either enzalutamide or abirateroneprednisone
Following determination of MTD and RP2D will proceed to phase 2 Patients in phase 2 will receive CPI-1205 at the RP2D in combination with either enzalutamide or abirateroneprednisone vs either enzalutamide or abirateroneprednisone as a control arm
Following determination of MTD and RP2D will proceed to phase 2 Patients in phase 2 will receive CPI-1205 at the RP2D in combination with either enzalutamide or abirateroneprednisone vs either enzalutamide or abirateroneprednisone as a control arm
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?:
None
Is an FDA AA801 Violation?:
None