NCT04716686

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma: A Multi-center, Open-label, Prospective Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endometrial Serous carcinoma (ESC) has similar molecular characteristics to high-grade serous ovarian carcinoma (HGSOC) and basal cell-like breast cancer, such as similar Chromosomal instability, somatic copy number variation profiles and somatic mutations. The clinical treatment of ESC also refers to the treatment model of HGSOC. The PARP inhibitor niraparib used in this study, which was approved by FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy on March 27, 2017. The homologous recombination related gene mutations in total endometrial cancer accounted for 22%. Homologous Recombination Repair Defect (HRD) +ARID1A accounted for 48%, and 53% of endometrial cancer cell lines were sensitive to PARP inhibitors. The incidence of HRD in endometrial cancer with high copy number (the pathological type is mainly ESC) is 50%, suggesting potential clinical applications of PARP inhibitors for the treatment of ESC.

Conditions

• Endometrial Carcinoma
• Serous Carcinoma

Interventions

Type	Name	Description
DRUG	Niraparib	Patients received oral niraparib 200/300 mg QD and every cycle (28 days) thereafter until disease progression.

Timeline

• Start date: 2021-06-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2021-01-20
• Last updated: 2024-01-05

Locations

1 site across 1 country: China