Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedSIR
About this trial
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.
Eligibility criteria
Qualifiers
Written informed consent form (ICF) prior to beginning specific protocol procedures.
Female patients ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Patients must have a life expectancy ≥16 weeks.
Disqualifiers
Patients with symptomatic or systemic progressive disease not fulfilling OMP disease criteria.
Patients with residual disease after secondary cytoreductive surgery.
Patients with persistent toxicities (> Common Terminology Criteria for Adverse Events (CTCAE) grade 2) caused by previous cancer therapy.
Patients unable to swallow oral medication or with any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of niraparib, or put the study outcomes at undue risk.
Trial design
Treatments tested in this trial
- Niraparib oral tablets
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov