Actively Recruiting
Phase II Study to Assess the Efficacy of 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of niraparib rechallenge treatment after secondary cytoreductive surgery in women with ovarian cancer who experience oligometastatic progression following first maintenance therapy with any PARP inhibitor. This phase II clinical trial focuses on patients with high grade serous or endometrioid ovarian cancer who have 1 to 5 metastatic lesions and no residual tumor after surgery. The main goal is to assess progression-free survival with niraparib treatment in this specific group. Participants will receive oral niraparib tablets at a dose of 300 or 200 mg daily, adjusted based on body weight or platelet count. Treatment will begin within 8 weeks after surgery and continue until disease progression or treatment discontinuation. The study includes no placebo group, and all enrolled patients will receive niraparib continuously in 28-day cycles. During the study, patients will undergo regular assessments including biomarker status evaluations, CA 125 monitoring, and overall survival tracking. Safety will be closely monitored by recording adverse events up to 7 months. Participants must be accessible for follow-up and provide tumor tissue and blood samples at specified intervals. The total participation period includes treatment and follow-up assessments for progression-free survival and overall survival.
CONDITIONS
Brief Title
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before starting the study.
- Female patients aged 18 years or older.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 16 weeks.
- Histologically confirmed high grade serous or endometrioid ovarian cancer with oligometastatic progression during or after first maintenance therapy with any PARP inhibitor.
- Oligometastatic progression defined as 1 to 5 metastatic lesions.
- Underwent secondary cytoreductive surgery with no visible residual tumor.
- Patients with asymptomatic and treated brain metastases under specific conditions.
- Documented BRCA1/2 and/or homologous recombination status.
- Prior PARP inhibitor maintenance treatment for at least 12 months or progression after treatment.
- No significant toxicity from prior niraparib if previously treated.
- Willing to provide tumor tissue and blood samples at defined times.
- Able to take oral medications.
- Treatment to start 3 to 8 weeks after surgery.
- Women of childbearing potential must use contraception and have a negative pregnancy test.
- Adequate bone marrow, liver, and kidney function.
- Accessible for treatment follow-up.
You will not qualify if you...
- Symptomatic or systemic progressive disease not fitting oligometastatic progression criteria.
- Residual disease after secondary cytoreductive surgery.
- Persistent toxicities greater than grade 2 from prior cancer therapy.
- Unable to swallow oral medication or have life-threatening illness or organ dysfunction affecting safety or treatment.
- Significant cardiovascular disease or recent serious cardiac events.
- Persistent grade 3 or higher blood cell abnormalities from prior PARP inhibitor therapy.
- Active HIV, hepatitis B or C infection, or uncontrolled systemic infection.
- Known allergy to niraparib or its ingredients.
- Recent transfusions or treatments that may affect study results.
- Participation in another clinical trial until study safety visit.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- History or signs of myelodysplastic syndrome or acute myeloid leukemia.
- Previous allogenic bone marrow or double umbilical cord blood transplant.
- Other malignancies unless cured with no disease for 5 years, with some exceptions.
- Vaccination with live virus vaccine within 28 days before treatment start.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or treatment discontinuation
Participants receive niraparib oral tablets once daily in 28-day cycles, starting 3 to 8 weeks after surgery, continuing until disease progression or treatment discontinuation.
Visits occur regularly during treatment cycles as per protocol
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
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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