Spots Global Cancer Trial Database for Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
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Trial Identification
Brief Title: Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
Official Title: Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency (GAUSS)
Study ID: NCT06237205
Conditions
Interventions
Study Description
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
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
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