Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

NCT06180356 | Recruiting Phase 2 DMC

• 1 other identifier: MEDOPP557
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Ovarian Cancer; Oligometastatic Disease; Serous Ovarian Tumor

Outcome Measures

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)

  Baseline up to 7 months

Secondary Outcomes (5)

• Progression free-survival according to biomarker status (BRCAm, BRCAwt, HRD and HRP)

  Baseline up to 7 months

• Progression free-survival by CA 125

  Baseline up to 7 months

• Time to start of first subsequent therapy or death (TFST)

  Baseline up to 7 months

• Overall survival (OS)

  Baseline up to 7 months

• Incidence of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions

  Baseline up to 7 months

Study Arms (1)

Niraparib

EXPERIMENTAL

Drug: Niraparib oral tablets

Interventions

Niraparib oral tablets DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Histologically confirmed high grade serous or endometrioid OC who have an OMP during or after the first maintenance therapy with any PARPi.
• Oligometastatic progression defined as 1-5 lesions (according to European Society for Radiotherapy and Oncology \[ESTRO\] and American Society for Radiation Oncology \[ASTRO\] consensus).
• Note: Metastatic lymph nodes located within the same anatomical lymph-node chain or station, as confirmed on surgical specimen, shall be counted collectively as one single metastatic lesion.
• Patients must have undergone secondary cytoreductive surgery with centrally confirmed no evidence of macroscopic residual tumor after surgery (complete resection).
• Patients with asymptomatic and treated brain metastases are allowed if:
• \. Neurosurgical resection ≥ 28 days prior to initiation of study treatment. 2. Not requiring radiotherapy. 3. Not receiving steroid therapy or anticonvulsant for at least 7 days before the first dose of study treatment.
• \. Documented breast cancer gene 1/2 (BRCA1/2) status and/or homologous recombination (HR) status.
• Note I: Patients with germline or somatic mutations in the BRCA1 or BRCA2 genes will be considered with the HR status known and classified as with homologous recombination deficiency (HRD).
• Note II: HR test must be performed before C1D1.
• \. Patients who have received prior PARPi monotherapy or PARPi together with bevacizumab as maintenance treatment.
• \. Patients should have had benefit of prior PARPi defined by treatment for ≥12 months from initiation of PARPi maintenance until the date of OMP or have experienced tumor progression after treatment completion. Tumor progression must have been confirmed by computed tomography (CT) and/or PET-CT scan.

You may not qualify if:

• 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.
• Patients with clinically significant cardiovascular disease such as uncontrolled hypertension, uncontrolled or symptomatic arrythmias, congestive heart failure (CHF), or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification.
• Patients treated with previous PARPi therapy who have any known, persistent (\>4 weeks), ≥Grade 3 anemia, neutrophil count decrease or platelet count decrease.
• Patients with known history of human immunodeficiency virus (HIV), or active hepatitis C Virus (HCV), or active hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.
• Patients with known hypersensitivity or allergy to prior niraparib treatment or any of the excipients of the product.
• Patients who have received a transfusion of platelets or red blood cells, colony-stimulating factors or have any other laboratory abnormality within 2 weeks prior niraparib treatment that might confound or interfere with the study result.
• Participation in another clinical trial, interventional or observational, until the Study's safety visit.
• Note: participation in retrospective studies or data analysis is allowed.
• Patients who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study treatment.
• Patients with myelodysplastic syndrome (MSD)/Acute myeloid leukemia (AML), with history of MSD/AML or with features suggestive of MDS/AML.
• Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
• Other malignancy unless curatively treated with no evidence of disease ≥ 5 years prior to study enrollment. Note: Patients with adequately non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) and stage 1 low grade endometrial carcinoma are not excluded.

Sponsors & Collaborators

• MedSIR: lead

Study Sites (14)

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

RECRUITING

Hospital de Cruces

Barakaldo, Spain

RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, Spain

RECRUITING

Institut Català d' Oncologia Girona (ICO)

Girona, Spain

RECRUITING

Complejo Hospitalario de Jaén

Jaén, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Hospital Universitari Sant Joan de Reus

Tarragona, Spain

RECRUITING

Hospital Arnau de Vilanova de Valencia

Valencia, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Alfonso Cortés Salgado

  Hospital Universitario Ramón y Cajal, IRYCIS, Madrid (Spain)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MEDSIR

CONTACT

+ 34 932 214 135; contact.trials@medsir.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 22, 2023
• Study Start: December 3, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14)