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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Niraparib oral tablets
DrugNiraparib 300 or 200 mg according to body weight or platelet count. Tablets will be taken orally, once daily, continuously (in 28-day cycles).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: NiraparibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
PFS is defined as the period of time from niraparib treatment initiation until the subsequent disease progression or death, whichever occurs first, as determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1)
Time frame
Baseline up to 7 monthsSecondary outcomes
1
Progression free-survival according to biomarker status (BRCAm, BRCAwt, HRD and HRP)
PFS by biomarker status is defined as the period of time from niraparib treatment initiation until the subsequent disease progression or death, whichever occurs first, as determined locally by the investigator through the use of RECIST v.1.1, in patients' subgroups
Time frame
Baseline up to 7 months2
Progression free-survival by CA 125
PFS by CA 125 is defined as the time from treatment initiation until disease progression or death, whichever occurs first, as determined locally by the investigator using Gynecologic Cancer Intergroup (GCIC) criteria for CA 125 biomarker
Time frame
Baseline up to 7 months3
Time to start of first subsequent therapy or death (TFST)
TFST is defined as the time from the date of treatment initiation to the earliest date of anti-cancer therapy start date following study treatment discontinuation, or death
Time frame
Baseline up to 7 months4
Overall survival (OS)
OS is defined as the period from treatment initiation to death from any cause, as determined locally by the investigator
Time frame
Baseline up to 7 months Source ClinicalTrials.gov