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 (May 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
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)
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.
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 qualify