OncoMatch/Clinical Trials/NCT06180356
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
Is NCT06180356 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Niraparib oral tablets for ovarian cancer.
Treatment: Niraparib oral tablets — The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with oligometastatic progression (OMP) after first maintenance therapy with any PARP inhibitor. A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg, according to body weight or platelet count. Patients will start treatment within 6 weeks after surgery and will receive it until progressive disease or treatment discontinuation. The main purpose of the study is to evaluate progression-free survival (PFS) of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Allowed: BRCA1 mutation
Documented breast cancer gene 1/2 (BRCA1/2) status
Allowed: BRCA2 mutation
Documented breast cancer gene 1/2 (BRCA1/2) status
Disease stage
Metastatic disease required
Grade: high grade
Oligometastatic progression defined as 1-5 lesions (according to European Society for Radiotherapy and Oncology [ESTRO] and American Society for Radiation Oncology [ASTRO] consensus)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: PARP inhibitor — maintenance
first maintenance therapy with any PARPi
Must have received: PARP inhibitor (niraparib) — maintenance
Patients should have had benefit of prior PARPi defined by exposure for ≥12 months (at least ≥ 18 months for patients who have a BRCA1/2 mutation) from initiation of PARPi maintenance until the date of OMP or have experienced a tumor progression after treatment completion
Cannot have received: PARP inhibitor (niraparib)
Exception: significant toxicity or need for treatment discontinuation
If prior treatment was niraparib, no significant toxicity or need for treatment discontinuation was required
Lab requirements
Blood counts
White blood cell (WBC) count > 3.0 x 10^9/L, absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 100.0 x10^9/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L)
Kidney function
serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Liver function
total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN
Patient has adequate bone marrow, liver, and renal function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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