RecruitingPhase 2NCT04716686

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


Sponsor

Shandong University

Enrollment

83 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests niraparib, a targeted drug that blocks a DNA repair protein, as a treatment for serous endometrial cancer (a type of uterine cancer) that is at an advanced stage or has come back after platinum-based chemotherapy. **You may be eligible if:** - You are a woman 18 or older diagnosed with serous endometrial cancer (stage III or IV) or another type of endometrial cancer - You have completed at least 6 cycles of platinum-based chemotherapy and your disease responded (stable or improved) - OR you have relapsed after multiple lines of chemotherapy and have a BRCA mutation or HRD (DNA repair deficiency) - Your blood counts and organ function meet minimum levels - You are willing to use contraception if you could become pregnant **You may NOT be eligible if:** - You have had prior treatment with a PARP inhibitor (like olaparib or rucaparib) - You have uncontrolled brain metastases - You have active HIV, hepatitis B, or hepatitis C - You have a history of myelodysplastic syndrome (MDS) or AML - You have had recent surgery or significant bone marrow radiation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiraparib

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


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT04716686


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