NCT04716686 is a Phase 2 clinical trial of Niraparib in Endometrial Carcinoma, sponsored by Shandong University.

Who is sponsoring NCT04716686?

NCT04716686 is sponsored by Shandong University.

What drugs are being tested in NCT04716686?

Interventions in NCT04716686: Niraparib.

What condition does NCT04716686 study?

NCT04716686 studies Endometrial Carcinoma, Serous Carcinoma.

Is NCT04716686 still recruiting?

NCT04716686 is currently recruiting now. Last updated 5 January 2024.

Last reviewed 2024-01-05 · How we verify

NCT04716686

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

Recruiting now Phase 2 Last updated 5 January 2024

What this trial tests

Phase 2 trial testing Niraparib in Endometrial Carcinoma in 83 participants. Currently enrolling.

Timeline

1 June 2021

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	Shandong University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	83
Start date	1 June 2021
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

Niraparib (niraparib) — full drug profile →

Conditions studied

Endometrial Carcinoma — all drugs for Endometrial Carcinoma →
Serous Carcinoma — all drugs for Serous Carcinoma →

Sponsor

Shandong University

Who can join

18 and older, female only, with Endometrial Carcinoma or Serous Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
Treating ARID1A mutated cancers by harnessing synthetic lethality and DNA damage response.
Mandal J, Mandal P, Wang TL, Shih IM. · · 2022 · cited 68× · PMID 36123603 · DOI 10.1186/s12929-022-00856-5
Targeting DNA Damage Repair and Immune Checkpoint Proteins for Optimizing the Treatment of Endometrial Cancer.
Bian X, Sun C, Cheng J, Hong B. · · 2023 · cited 3× · PMID 37765210 · DOI 10.3390/pharmaceutics15092241
Development of New Cancer Treatment by Identifying and Focusing the Genetic Mutations or Altered Expression in Gynecologic Cancers.
Tang YH, Lin CY, Lai CH. · · 2021 · cited 1× · PMID 34680987 · DOI 10.3390/genes12101593

Verify or expand the search:

Other trials of Niraparib

Trials testing the same drug.

NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
NCT06682780 — A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours · Phase 1, PHASE2 · recruiting
NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
NCT06887933 — A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ov · Phase 4 · not yet recruiting
NCT05672095 — Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer · Phase 1, PHASE2 · withdrawn

Other recruiting trials for Endometrial Carcinoma

Currently open trials in the same condition.

NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07062016 — Molecular and ctDNA Characterization of High-Risk Endometrial Cancer · recruiting
NCT07407959 — Screening and Staging of Benign vs Malignant Pelvic Abnormalities · recruiting
NCT06855706 — An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV · NA · recruiting
NCT06632431 — Clinicopathological Analysis of Endometrial Carcinoma in the View of Old and New International Federation of Gynecology · recruiting

Other Shandong University trials

Trials by the same sponsor.

NCT07288346 — Effect of Predictive Model on Double-Balloon Enteroscopy · NA · recruiting
NCT07325344 — Active Locomotion of Magnetically Controlled Capsule Endoscopy in the Small Bowel: A Feasibility Study · NA · recruiting
NCT07319312 — Evaluating the Effect of Nurse-Led Stroke Transitional Care in Tanzania · recruiting
NCT07391787 — Low-acid Contrast Media for Preventing Post ERCP Pancreatitis · completed
NCT07066059 — Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04716686 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shandong University
Last refreshed: 5 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04716686.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing