Actively Recruiting
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
Led by MedSIR · Updated on 2026-04-22
30
Participants Needed
14
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 16 weeks
- Histologically confirmed high grade serous or endometrioid ovarian cancer
- Oligometastatic progression defined as 1-5 lesions
- Secondary cytoreductive surgery with no visible residual tumor confirmed
- Asymptomatic and treated brain metastases allowed if neurosurgery was at least 28 days prior, no radiotherapy needed, and no recent steroid or anticonvulsant use
- Documented BRCA1/2 and/or homologous recombination status
- Prior maintenance treatment with PARP inhibitor monotherapy or with bevacizumab
- Benefit from prior PARP inhibitor treatment for at least 12 months or tumor progression confirmed after treatment completion
- No significant toxicity from prior niraparib treatment if previously used
- Willingness to provide tumor tissue and blood samples at specified times
- Able to take oral medication
- Treatment to start 3 to 8 weeks after surgery
- Use of contraception for women of childbearing potential and negative pregnancy test before treatment
- Adequate bone marrow, liver, and kidney function
- Accessible for treatment follow-up
You will not qualify if you...
- Symptomatic or systemic progressive disease not meeting oligometastatic progression criteria
- Residual disease after secondary cytoreductive surgery
- Persistent toxicities greater than grade 2 from previous cancer therapy
- Inability to swallow oral medication or any life-threatening condition affecting safety or drug absorption
- Significant cardiovascular disease including uncontrolled hypertension, arrhythmias, congestive heart failure, recent myocardial infarction, or severe heart disease
- Previous PARP inhibitor therapy with persistent grade 3 or higher anemia or low neutrophil or platelet counts
- Known HIV, active hepatitis B or C infection, or uncontrolled systemic infection requiring IV antibiotics
- Known allergy to niraparib or its components
- Recent transfusions or laboratory abnormalities that could affect study results
- Participation in other clinical trials until safety visit (retrospective studies allowed)
- Pregnancy, breastfeeding, or planning pregnancy during the study
- History or features of myelodysplastic syndrome or acute myeloid leukemia
- Previous allogenic bone marrow or double umbilical cord blood transplantation
- Other malignancies unless curatively treated with no evidence of disease for at least 5 years, except certain non-melanoma skin or in situ cancers
- Vaccination with live virus vaccine within 28 days prior to treatment initiation
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, Spain
Actively Recruiting
2
Hospital de Cruces
Barakaldo, Spain
Actively Recruiting
3
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Actively Recruiting
4
Institut Català d' Oncologia Girona (ICO)
Girona, Spain
Actively Recruiting
5
Complejo Hospitalario de Jaén
Jaén, Spain
Actively Recruiting
6
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
7
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
8
Hospital Universitario Ramón y Cajal
Madrid, Spain
Actively Recruiting
9
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Actively Recruiting
10
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Spain
Actively Recruiting
11
Hospital Universitario Virgen Macarena
Seville, Spain
Actively Recruiting
12
Hospital Universitari Sant Joan de Reus
Tarragona, Spain
Actively Recruiting
13
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Actively Recruiting
14
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Actively Recruiting
Research Team
M
MEDSIR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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