Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03786796
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2018-12-21
Brief Title:
Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations ORCHID
Status:
RECRUITING
Status Verified Date:
2024-03
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:
ORCHID
Brief Summary:
Single arm single site open-label Phase II study of the effects of oral olaparib in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1 ATM BRCA1 BRCA2 PALB2 CHEK2 BRIP1 RAD51C BARD1 CDK12 CHEK1 FANCL PP2R2A RAD51B RAD51D or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy Must have measurable disease on CT imaging per RECIST 11 criteria
Detailed Description:
The trial will enroll up to 20 participants Following enrollment participants will be initially treated with olaparib 150mg by mouth twice daily for one month After one month of therapy the dose of olaparib will be increased to 300mg by mouth twice daily provided there are no grade 3 or greater adverse events experienced All participants will be reassessed at least monthly for toxicity including laboratory investigations Radiological scans will be performed approximately every 3 months to assess for disease response Treatment will be continued until clinical andor radiographic progression according to RECIST 11 criteria or unmanageable toxicity requiring cessation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB00197147 | OTHER | JHM IRB | None |