Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-08
Brief Title:
Genome-Based Assessment of Niraparib ZEJULA Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
Genome-Based Assessment of Niraparib ZEJULA Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency GAUSS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
Investigational Products Niraparib Period 3 years after IRBEC approval Indication Adult patients with histologically confirmed and locally advanced unresectable or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair HRR or homologous recombination deficiency identified by whole genome sequencing
Detailed Description:
Objectives
1 Primary Objective
- Antitumor activity defined as objective response at 8 weeks or stable disease SD at 16 weeks from the time of enrollment
2 Secondary Objectives
Overall Survival OS
Progression-Free Survival PFS
Objective Response Rate ORR by RECIST v11
Duration of response DOR
Quality of life QOL assessed by EORTC-QLQ-C30
Adverse Event AEs
Exploratory biomarker analyses
1 Primary Objective
- Antitumor activity defined as objective response at 8 weeks or stable disease SD at 16 weeks from the time of enrollment
2 Secondary Objectives
Overall Survival OS
Progression-Free Survival PFS
Objective Response Rate ORR by RECIST v11
Duration of response DOR
Quality of life QOL assessed by EORTC-QLQ-C30
Adverse Event AEs
Exploratory biomarker analyses
Study Oversight
Has Oversight DMC:
None
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?:
None