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

Sponsor
Korea University Anam Hospital
Study ID
NCT06237205
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Efficacy

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    a highly selective PARP1 and PARP2 inhibitor

Study Details

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

Key Dates

Start date
Feb 27, 2024
Status verified
Jan 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib

Primary Outcome Measure

objective response after 8 weeks [ Time Frame: at 8 weeks after Cycle 1 Day 1(each cycle is 28 days) ]

Central Contacts

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