RecruitingPhase 2NCT06141265

Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

Chemotherapy Combined With Bevacizumab Followed by Niraparib Monotherapy in Newly Diagnostic Advanced Ovarian Cancer With HRD Positive : A Perspective, Multicenter, Single-arm Phase II Trial


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

116 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC), including primary peritoneal and/or fallopian tube tumors, following response to front-line chemotherapy in combination with bevacizumab. A total of 116 patients will be enrolled.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests niraparib — a targeted drug called a PARP inhibitor — as maintenance therapy in women with advanced ovarian, fallopian tube, or peritoneal cancer whose tumors have a DNA repair deficiency (called HRD-positive). The drug is given after completing front-line chemotherapy plus bevacizumab to try to keep the cancer from coming back. **You may be eligible if...** - You are female and 18 or older - You have high-grade ovarian, fallopian tube, or primary peritoneal carcinoma confirmed by biopsy - Your cancer is Stage III or IV - You had surgery to remove as much cancer as possible (primary or interval debulking surgery) - You have completed chemotherapy with bevacizumab - Your tumor is HRD-positive (has a specific DNA repair gene problem, often a BRCA mutation) **You may NOT be eligible if...** - Your tumor is HRD-negative - You have not completed the required chemotherapy regimen - You did not have debulking surgery - You do not meet organ function requirements 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

The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count


Locations(1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06141265