Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03012321
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-30
First Post:
2017-01-03
Brief Title:
AbirateronePrednisone Olaparib or AbirateronePrednisone Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
BRCAAway A Randomized Phase II Trial of Abiraterone Olaparib or Abiraterone Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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 is a biomarker preselected randomized open-label multicenter phase II study in men with metastatic castration resistant prostate cancer mCRPC Patients with tumors that have ATM BRCA1 andor BRCA2 mutationsdeletionsloss of heterozygosity will be randomized in a 111 fashion to each arm Patients with mutations in noncanonical DNA repair genes including FANCA PALB2 RAD51 ERCC3 MRE11 NBN MLH3 CDK12 CHEK2 HDAC2 ATR PMS2 GEN1 MSH2 MSH6 BRIP1 or FAM175A defects will be assigned to Arm IV with single agent olaparib
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STU00203960 | OTHER | None | None |
| NCI-2016-01834 | REGISTRY | None | None |
| PCCTC c16-168 | OTHER | PCCTC | None |