OncoMatch/Clinical Trials/NCT04716686
Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
Is NCT04716686 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Niraparib for endometrial carcinoma.
Treatment: Niraparib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: BRCA1 any mutation
patients with other types of endometrial cancer have received >2 lines of platinum containing chemotherapy and have BRCA mutation or be defined as HRD positive
Required: BRCA2 any mutation
patients with other types of endometrial cancer have received >2 lines of platinum containing chemotherapy and have BRCA mutation or be defined as HRD positive
Disease stage
Required: Stage FIGO STAGE III, FIGO STAGE IV (FIGO)
Excluded: Stage STAGE IA(ON INVASION TO MYOMETRIUM)
FIGO stage III-IV; Stage Ia(on invasion to myometrium) [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — adjuvant/first-line and/or relapse
ESC Patients have received at least 6 cycles of first-line platinum containing chemotherapy after surgery and achieved CR, PR or SD; ESC patients have received platinum containing chemotherapy after the first relapse and achieved CR, PR or SD
Must have received: platinum-based chemotherapy — recurrent/metastatic
ESC Patients have received >2 lines of platinum containing chemotherapy and relapsed; patients with other types of endometrial cancer have received >2 lines of platinum containing chemotherapy and have BRCA mutation or be defined as HRD positive
Cannot have received: PARP inhibitor
Have received any PARP inhibitor treatment previously
Lab requirements
Blood counts
Neutrophil count ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥10g/dL
Kidney function
Serum creatinine ≤1.5 times of the upper limit, or creatinine clearance ≥60mL/min
Liver function
Total bilirubin ≤1.5 times of the upper limit or direct bilirubin ≤1.0 times of the upper limit; AST and ALT ≤2.5 times of the upper limit, and must be ≤5 times of the upper limit of when liver metastasis exists.
Laboratory criteria are as follows: Neutrophil count ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥10g/dL; Serum creatinine ≤1.5 times of the upper limit, or creatinine clearance ≥60mL/min; Total bilirubin ≤1.5 times of the upper limit or direct bilirubin ≤1.0 times of the upper limit; AST and ALT ≤2.5 times of the upper limit, and must be ≤5 times of the upper limit of when liver metastasis exists.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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