OncoMatch/Clinical Trials/NCT06180356
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
Is NCT06180356 recruiting? Yes, currently enrolling (Sep 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 8 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
Treatments studied
Other
Cancer type
Ovarian Cancer
Biomarker criteria
Required: BRCA1 mutation
Required: BRCA2 mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: parp inhibitor — maintenance
Cannot have received: parp inhibitor (niraparib)
Exception: no significant toxicity that led to treatment discontinuation
Cannot have received: allogenic bone marrow transplant or double umbilical cord blood transplantation
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06180356 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior parp inhibitor, allogenic bone marrow transplant or double umbilical cord blood transplantation disqualifies patients from enrollment.
Does this trial require BRCA1?
Yes, BRCA1 mutation is a required biomarker for enrollment.
Does this trial require BRCA2?
Yes, BRCA2 mutation is a required biomarker for enrollment.
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