NCT06237205

Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency

Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency (GAUSS)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Efficacy

Interventions

Type	Name	Description
DRUG	Niraparib	a highly selective PARP1 and PARP2 inhibitor

Timeline

• Start date: 2024-02-27
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2024-02-01
• Last updated: 2024-02-01