Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-29 @ 2:34 AM
Study NCT ID:
NCT03044795
Status:
WITHDRAWN
Last Update Posted:
2024-05-03
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response to PARP Inhibitor Predicted by the RAD51 Assay
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Phase II Study With PARP Inhibitor Veliparib (ABT-888) in Patients With Increased Risk of Homologous Recombination Deficiency to Determine the Value of an (Ex-vivo) RAD51 Assay as a Biomarker
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIR
Brief Summary:
In tumors with a defect in the homologous recombination (HR) pathway, double-strand break repair is partly impaired. Patients with HR deficient tumors benefit from therapies that induce DNA lesions requiring HR for repair. These therapies include platinum compounds and inhibitors of the enzyme PARP-1. At this moment, selection for PARP inhibitor treatment relies on detection of germ-line or somatic mutations in the HR pathway genes BRCA1 or BRCA2. However, not all HR deficient tumors have a BRCA gene mutation, the BRCA genes can also be silenced by promoter methylation. Moreover, the HR pathway can be defective due to mutations in other HR genes. In addition, the presence of a BRCA gene mutation does not guarantee defective HR since mutations in other genes (e.g. TP53BP1) can restore HR despite the presence of a BRCA1 mutation. Since all patients with tumors that are HR deficient may benefit from PARP inhibition, better tools are required to identify these patients. Recently, a functional ex vivo test for HR deficiency (the RAD51 assay) became available for clinical use. The RAD51 assay can identify patients with functional defects in HR-repair and may predict which cancer patients are likely to benefit from PARP inhibition. The purpose of this study is to investigate whether the RAD51 assay can select patients who will benefit from treatment with the PARP-inhibitor veliparib.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: