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Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

NCT04716686 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-01-05

No results posted yet for this study

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

DRUG

Niraparib

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

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Women's Hospital School Of Medicine Zhejiang University

    collaborator OTHER

  • Zai Lab (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • Shandong University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04716686 on ClinicalTrials.gov