Ovarian CancerPhase 2ANALLISANCT06180356
Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression
A Phase 2 study testing Niraparib oral tablets in people with Ovarian Cancer and Oligometastatic Disease, run by MedSIR at 14 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Oligometastatic Disease, Serous Ovarian Tumor
- What is being tested?
- Niraparib oral tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 14 sitesSpain
- Study dates
- 3 Dec 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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:
- 1. 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.
- 9. 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.
- 10. Patients who have received prior PARPi monotherapy or PARPi together with bevacizumab as maintenance treatment.
- 11. 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.
- 12. If prior treatment was niraparib, no significant toxicity that led to treatment discontinuation.
- 13. Willingness to provide formalin fixed, paraffin embedded (FFPE) tumor tissue from primary, if available, and secondary surgeries and blood samples at the time of the inclusion, every 12 weeks, and at the end of treatment (EoT).
- 14. Able to take oral medications. 15. Patients must start treatment 3 to 8 weeks from surgery, once recovered from surgery.
- 16. Women of childbearing potential who engage in heterosexual intercourse must agree to use institution specified method(s) of contraception and must refrain from donating eggs in the time period specified in the study protocol. Women of childbearing potential must have a negative serum or a highly sensitive urine pregnancy test within 72 hours before study treatment initiation.
- 17. Patient has adequate bone marrow, liver, and renal function:
- Hematological: White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x109/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6 mmol/L).
- Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN. 11).
- Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- 18. Patients must be accessible for treatment follow-up.
Who cannot join
- 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.
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- 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.
- Vaccination with any live virus vaccine within 28 days prior study treatment initiation.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Spain14 sites, 14 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña
- Recruiting
Hospital de Cruces
Barakaldo
- Recruiting
Hospital Universitari Vall D'Hebron
Barcelona
- Recruiting
Institut Català d' Oncologia Girona (ICO)
Girona
- Recruiting
Complejo Hospitalario de Jaén
Jaén
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
- Recruiting
Hospital Universitario La Paz
Madrid
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
- Recruiting
Hospital Universitario Central de Asturias (HUCA)
Oviedo
- Recruiting
Hospital Universitario Virgen Macarena
Seville
- Recruiting
Hospital Universitari Sant Joan de Reus
Tarragona
- Recruiting
Hospital Arnau de Vilanova de Valencia
Valencia
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia
About this study
Official title: Phase II Study to Assess the Efficacy of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression (The ANALLISA Study)
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.
Read the detailed description
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 systemic 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 8 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 time to start of first subsequent therapy or death (TFST) and the overall survival (OS).
- Being tested
- Niraparib oral tablets
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib oral tabletsDrug
Niraparib 300 or 200 mg according to body weight or platelet count. Tablets will be taken orally, once daily, continuously (in 28-day cycles).
| Study group | Role | What they receive |
|---|---|---|
| Niraparib | Experimental | Not described Receives: Drug: Niraparib oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline up to 7 months
Secondary outcomes (5)
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
Measured: Baseline up to 7 months
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
Measured: Baseline up to 7 months
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
Measured: Baseline up to 7 months
Overall survival (OS)
OS is defined as the period from treatment initiation to death from any cause, as determined locally by the investigator
Measured: Baseline up to 7 months
Incidence of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
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)
Measured: Baseline up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start3 Dec 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfonso Cortés Salgado, Principal investigator, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180356
- Sponsor's protocol ID
- MEDOPP557
- Acronym
- ANALLISA
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Assess the Efficacy of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression (The ANALLISA Study)
- ClinicalTrials.gov ID
- NCT06180356
- Acronym / sponsor ID
- ANALLISA / MEDOPP557
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 systemic 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 8 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 time to start of first subsequent therapy or death (TFST) and the overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib | Experimental | Drug: Niraparib oral tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib oral tabletsNiraparib 300 or 200 mg according to body weight or platelet count. Tablets will be taken orally, once daily, continuously (in 28-day cycles). | Drug | Niraparib |
Primary outcome
Progression-free survival (PFS)
Time frame: Baseline up to 7 months
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)
5 secondary outcomes
Progression free-survival according to biomarker status (BRCAm, BRCAwt, HRD and HRP)
Time frame: Baseline up to 7 months
Progression free-survival by CA 125
Time frame: Baseline up to 7 months
Time to start of first subsequent therapy or death (TFST)
Time frame: Baseline up to 7 months
Overall survival (OS)
Time frame: Baseline up to 7 months
Incidence of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions
Time frame: Baseline up to 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alfonso Cortés Salgado principal investigator
Hospital Universitario Ramón y Cajal, IRYCIS, Madrid (Spain)
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib oral tablets in people with Ovarian Cancer and Oligometastatic Disease, run by MedSIR at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MEDSIR (+ 34 932 214 135, contact.trials@medsir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Baseline up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.