Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
NCT06141265 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2023-11-21
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.
Conditions
- Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Interventions
- DRUG
-
Niraparib
The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Sponsors & Collaborators
-
Peking University Cancer Hospital & Institute
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2026-09-30
- Completion
- 2027-09-30
Countries
- China
Study Locations
More Related Trials
-
Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor
NCT04734665 ·Status: UNKNOWN ·Phase: PHASE2
-
Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer
NCT02354131 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
NCT06827353 ·Status: RECRUITING
-
Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer
NCT04986371 ·Status: UNKNOWN
-
NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.
NCT04861181 ·Status: TERMINATED ·Phase: PHASE4
-
Efficacy and Safety of Niraparib Combined With Bevacizumab in Platinum Refractory/Resistant Recurrent Ovarian Cancer
NCT04556071 ·Status: UNKNOWN ·Phase: PHASE2
-
A Real-World Patient-Reported Outcomes Study in Patients With Long-Term Use of Niraparib
NCT06037213 ·Status: UNKNOWN
-
Efficacy and Safety of Niraparib Combined With Oral Etoposide in Platinum Resistant/Refractory Recurrent Ovarian Cancer
NCT04217798 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer
NCT03709316 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficacy and Adverse Effects of Niraparib in Ovarian Cancer.
NCT05583799 ·Status: UNKNOWN
-
Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer
NCT06954584 ·Status: RECRUITING ·Phase: PHASE3
-
Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT03586661 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
NCT06735326 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Niraparib in Patients With Relapsed Ovarian Cancer
NCT04392102 ·Status: COMPLETED ·Phase: PHASE2
-
Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NCT00951496 ·Status: COMPLETED ·Phase: PHASE3
-
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
NCT01081262 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT02655016 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting
NCT04284852 ·Status: COMPLETED ·Phase: PHASE2
-
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
NCT06121401 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
First-line Olaparib Combined With Bevacizumab Maintenance Therapy
NCT05440578 ·Status: UNKNOWN
-
Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer
NCT07059676 ·Status: NOT_YET_RECRUITING
-
Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study
NCT05734911 ·Status: COMPLETED
-
Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
NCT04507841 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy
NCT04229615 ·Status: UNKNOWN ·Phase: PHASE3
-
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
NCT06580314 ·Status: RECRUITING ·Phase: PHASE3