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Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 5, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jul 30, 2023 to Dec 31, 2025
    • Start date changed from estimate of Feb 1, 2021 to Jun 1, 2021
    • Study completion date: Jul 30, 2023 to Dec 31, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04716686
Lead Sponsor Shandong University
Collaborators: Sun Yat-sen University, Tongji Hospital, Women's Hospital School Of Medicine Zhejiang University, Zai Lab (Shanghai) Co., Ltd.
Conditions
(from sponsor)		 Endometrial Carcinoma, Serous Carcinoma
Related terms Cystadenocarcinoma, Serous, Endometrial Neoplasms
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov