Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
This is a multi-institutional Phase I dose-escalation and dose-expansion trial for patients
with advanced, solid tumor malignancies who have pre-identified deleterious germline or
somatic mutations in the homologous recombination deoxyribonucleic acid (DNA) repair pathway
(HR deficient). The trial is designed to assess the efficacy and safety of niraparib plus
carboplatin in patients with evidence of HRD. The primary endpoint will be identifying the
recommended phase 2 dose (RP2D) and schedule of niraparib plus carboplatin, as well as
establishing the anti-tumor efficacy of niraparib plus carboplatin as determined by Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.