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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
a highly selective PARP1 and PARP2 inhibitor
objective response after 8 weeks
Antitumor activity defined as objective response after 8 weeks
Time frame: at 8 weeks after Cycle 1 Day 1(each cycle is 28 days)
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