OncoMatch/Clinical Trials/NCT06594679
A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
Is NCT06594679 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Niraparib Tosylate Monohydrate for ovarian cancer.
Treatment: Niraparib Tosylate Monohydrate — This is an interventional trial. The goal of this clinical trial is dose finding. There are two phases: phase Ib to determine the MTD and recommended phase II dose of niraparib in combination with abemaciclib in patients with advanced ovarian cancer. Target population will be patients (woman, age \> 18 years) with epithelial ovarian, fallopian tube or peritoneal cancer treated with at least 2 lines of therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin) — platinum sensitive disease (> 6 months)
Patients must have completed at least 2 previous chemotherapy regimens for platinum sensitive disease (> 6 months). Patients must have completed their last therapy regimen > 4 weeks prior to treatment initiation and have radiological confirm of progression disease.
Cannot have received: immunologic agents
Any other prior therapy directed at the malignant tumor, including immunologic agents administered within 4 weeks prior to first dose of study drug
Lab requirements
Blood counts
ANC ≥ 1500/L (within 14 days of study drugs initiation); Hemoglobin (Hgb) > 9 g/dL with no blood transfusion in the past 14 days; Platelets > 100,000/L (within 14 days of study drug[s] initiation) with no platelets transfusion in the past 14 days
Kidney function
calculated or measured creatinine clearance of ≥ 50 mL/min according to Cockroft-Gault
Liver function
ALT and AST ≤ 2.5 x ULN or ≤ 5 x ULN if known hepatic metastases; serum bilirubin within normal limits (WNL) or ≤ 1.5 x ULN in patients with liver metastases; or total bilirubin ≤ 2.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's syndrome
Cardiac function
No unstable angina pectoris, congestive heart failure, acute myocardial infarction, uncontrolled conduction abnormality, significant ventricular or supraventricular arrhythmias, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, sudden cardiac arrest, QTcF > 470 msec, or congenital/acquired long QT syndrome
Absolute neutrophil count (ANC) ≥ 1500/L (within 14 days of study drugs initiation). Hemoglobin (Hgb) > 9 g/dL with no blood transfusion in the past 14 days (within 14 days of study drug[s] initiation). Platelets > 100,000/L (within 14 days of study drug[s] initiation) with no platelets transfusion in the past 14 days. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if known hepatic metastases (within 14 days of study drugs initiation). Serum bilirubin within normal limits (WNL) or ≤ 1.5 x ULN in patients with liver metastases; or total bilirubin ≤ 2.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's syndrome (within 14 days of study drugs initiation). Patients should have calculated or measured creatinine clearance of ≥ 50 mL/min according to Cockroft-Gault. Evidence of corrected QT interval (specifically QTc calculated using the Fridericia formula [QTcF]) > 470 msec from a single electrocardiogram (ECG) performed at study entry or congenital or acquired long QT syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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