Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency
NCT06237205 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2024-02-01
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
Conditions
- Efficacy
Interventions
- DRUG
-
Niraparib
a highly selective PARP1 and PARP2 inhibitor
Sponsors & Collaborators
- collaborator INDUSTRY
-
Korean Cancer Study Group
collaborator OTHER -
Korea University Anam Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-27
- Primary Completion
- 2026-06-30
- Completion
- 2027-06-30
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