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Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Niraparib 300 or 200 mg according to body weight or platelet count. Tablets will be taken orally, once daily, continuously (in 28-day cycles).

Niraparib oral tablets

Susana Vitorino

Alfonso Cortés Salgado

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.

This is a single-arm phase II clinical trial which will enroll female patients aged ≥ 18 years with high grade serous or endometrioid ovarian cancer (OC) who have had an oligometastatic progression (OMP) during or after the first maintenance therapy with any poly adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi). OMP is defined as 1-5 metastatic lesions. Patients with symptomatic metastatic disease are not eligible.

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 objective 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. Main secondary objectives are to assess the PFS according to biomarker status (BRCAm, BRCAwt, HRD and HRP), the PFS by CA 125, the second progression-free survival (PFS2), the time to start of first subsequent therapy or death (TFST) and the overall survival (OS).

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

Phase II Study to Assess the Efficacy of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression (The ANALLISA Study)

To analyze the correlation between PFS and type of prior PARPi maintenance treatment

To analyze the correlation between PFS and previous benefit to PARPi (progression during or after PARPi)

To analyze the association between changes in circulating tumor DNA (ctDNA) levels and patient outcomes

To evaluate changes in health-related quality-of-life (QoL) assessment using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present).

To determine new oncological biomarkers of radiological imaging - such as growth rate of tumor derived by tumor growth rate modeling or tumor heterogeneity according to quantitative estimation through radiomics - that could help to better understand the efficacy of drug treatments.

To analyze the correlation of biomarkers related to PARPi resistance with patient outcomes

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)

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

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

PFS2 is defined as the time from treatment initiation to the earliest progression event after that used for the primary variable PFS, or date of death as determined locally by the investigator using RECIST v.1.1

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

OS is defined as the period from treatment initiation to death from any cause, as determined locally by the investigator

Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs) according to the National Cancer Institute (NCI) CTCAE Version 5.0 (v.5.0) (Safety and Tolerability)

Spots Global Cancer Trial Database for niraparib oral tablets