Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06237205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
Sponsor:
Korea University Anam Hospital
Organization:
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 IRB/EC 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 v1.1
* 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 v1.1
* Duration of response (DOR)
* Quality of life (QOL) assessed by EORTC-QLQ-C30
* Adverse Event (AEs)
* Exploratory biomarker analyses
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?: