OncoMatch/Clinical Trials/NCT05961124
Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer
Is NCT05961124 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Niraparib for ovarian cancer.
Treatment: Niraparib — The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are: What is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and discontinuation? What is the length of time of progression-free survival at 24 months?
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Ovarian Cancer
Biomarker criteria
Excluded: BRCA1 mutation
Excluded: BRCA2 mutation
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin) — frontline
Patients must have completed a minimum of 4 cycles of platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin). Primary or interval debulking therapy and intraperitoneal chemotherapy are allowed.
Cannot have received: PARP inhibitor
Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a trial where PARP inhibitors were administered in one arm of the trial.
Lab requirements
Blood counts
Absolute neutrophil count 3E/= 1.5 x10^9/L; Platelets 3E/= 100 x10^9/L; Hemoglobin 3E/= 100 g/L without transfusion
Kidney function
Creatinine clearance 3E/= 60 mL/min using the Cockcroft-Gault equation
Liver function
Total bilirubin 3C=/= 1.5 x ULN or direct bilirubin < 1 x ULN; AST and ALT 3C=/= 2.5 x ULN unless liver metastases are present, in which case they must be 3C=/= 5 x ULN
Cardiac function
QT prolongation >470 milliseconds at screening [excluded]
Absolute neutrophil count 3E/= 1.5 x109/L; Platelets 3E/= 100 x109/L; Hemoglobin 3E/= 100 g/L without transfusion; Creatinine clearance 3E/= 60 mL/min using the Cockcroft-Gault equation; Total bilirubin 3C=/= 1.5 x ULN or direct bilirubin < 1 x ULN; AST and ALT 3C=/= 2.5 x ULN unless liver metastases are present, in which case they must be 3C=/= 5 x ULN; QT prolongation >470 milliseconds at screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05961124 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PARP inhibitor disqualifies patients from enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 mutation is an exclusion criterion.
What disease stage is eligible?
Stage III or IV is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages