A Phase 2 interventional study of Niraparib oral capsule and SBRT in Ovarian Cancer Recurrent, sponsored by Institute of Cancer Research, United Kingdom. Recruiting at 7 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Institute of Cancer Research, United Kingdom · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 44 studies testing niraparib in Ovarian Neoplasms — 9 open to participants now, 14 under way, 2 of them phase 3. niraparib · Ovarian Neoplasms.
Among the 44 studies testing niraparib in Ovarian Neoplasms, this one is the 21st largest by planned enrollment, is one of 3 that started in 2024, is one of 18 in phase 2, reaches primary completion later than 11 of the 13 other live ones, and was the 38th registered.
3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.
Browse Ovarian Neoplasms studies →9 of the 44 studies testing niraparib in Ovarian Neoplasms are open now, in 10 countries. Recruiting first, the newest first:
University of Miami · Sites in United States, Nigeria
Ages 18+ · Women only
MedSIR · Sites in Spain
Ages 18+ · Women only
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Sites in Italy
Ages 18+ · Women only
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18+ · Women only
University Health Network, Toronto · Sites in Canada
Ages 18+ · Women only
By country, each count listing its studies:
niraparib: first FDA approval 2017 (ZEJULA), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, niraparib is the treatment under test here. Read study by study →
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 22 · Phase 3 7 · Phase 4 5
First in 2008; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 42 is below the median of 54 across 2,552 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 41 across the 44 interventional studies. Of the 21 that completed or were terminated, 10 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 44 have an industry lead sponsor. The 10 most frequent:
Institute of Cancer Research, United Kingdom is the lead sponsor of 113 studies on the registry; 27 are open to participants now.
Institute of Cancer Research, United Kingdom has 4 studies filed under Ovarian Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies testing niraparib in Ovarian Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04641247GlaxoSmithKlineA Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study | 2026-12-28 |
| NCT06594679Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoA Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL) | 2027-03-20 |
Add all 2 to your calendar (.ics) → With an account.
Among the 44 studies testing niraparib in Ovarian Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
SOPRANO is a multi-centre phase II trial designed to assess the impact of SBRT with or without continuing treatment with a PARP inhibitor (PARPi) for patients with oligometastatic or oligoprogressive ovarian, fallopian tube and primary peritoneal carcinoma. SOPRANO will also establish the feasibility and acceptability of delivering SBRT in this setting.
Oligometastases or oligoprogression of ovarian cancer while on a PARPi may occur due to a secondary sub-clonal mutation causing acquired resistance in a small volume of tumour rather than having global tumour resistance. Eradication of the resistant disease with stereotactic radiotherapy (SBRT) would enable continuation of the PARPi to maintain control of disease that has retained drug sensitivity and this has the potential to impact disease outcomes.
For the purposes of this ovarian cancer trial, oligoprogression refers to the situation whereby 3 or less lesions of disease show evidence of progression. If there were previously other sites of disease, these remain in response or stable. Oligometastatic disease refers to the situation whereby complete response to treatment has been obtained and the disease relapse occurs that is limited in number and distribution (≤3 metastatic/recurrent lesions).
SOPRANO will explore whether there is activity of SBRT and SBRT followed by niraparib in the case of oligometastatic or oligoprogression disease post prior PARPi in recurrent ovarian cancer.
The trial will recruit patients with oligometastic or oligoprogressive ovarian cancer (≤3 sites/lesions) who have progressed on or following at least 6 months of treatment with PARP Inhibitor (PARPi). Participants may enter one of two parallel non-comparative treatment cohorts:
In both cohorts, therapy will continue until disease progression deemed by the investigator to warrant a change in treatment, unacceptable toxicity, withdrawal of consent or if the investigator decides it is not in the best interest of the patient to continue.
Adverse events, including toxicity from trial treatment will be collected and graded according to The National Cancer Institute (NCI) Common Terminology Criteria (CTC) Version 5.0 (http://ctep.cancer.gov/reporting/ctc.html).
Participants will be asked to consent for future linkage with routinely collected health data via national registries to trace their eventual vital status and assess subsequent unexpected comorbidities.
Assessment of disease by RECIST will be required 8 weekly following completion of SBRT for the first year and 12 weekly thereafter until disease progression meeting the primary endpoint.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women of who are confirmed NOT to be pregnant. This should be evidenced by a negative urine or serum pregnancy test within 72 hours prior to start of trial treatment. Patients will be considered to be not of child-bearing potential if they are:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated. Niraparib treatment will start 4 weeks post completion of SBRT treatment and will continue daily until disease progression or other discontinuation criteria are met. Niraparib comes in oral tablet form and the starting dose will be 200mg per day (once a day) or 300mg per day (once a day) calculated by participant's weight and platelet count.
Drug: Niraparib oral capsule · Radiation: SBRT
SBRT treatment will commence within 7 days post trial entry and will be administered as detailed in the SOPRANO Radiotherapy Planning and Delivery Guidelines document. Doses will vary between 3 fractions over 5 days to 8 fractions over 19 days depending on the location of the lesions being treated.
Radiation: SBRT
Niraparib used following SBRT treatment until disease progression
Also known as: Zejula
SBRT may be delivered using a specialist SBRT platform, such as CyberKnife or with a linear accelerator with SBRT capabilities.
Also known as: Stereotactic Body Radiotherapy
Progression free survival
Progression free survival is defined as time from trial entry to evidence of progression of cancer at any site or death from any cause. Progression events should be imaging defined in all tumour types according to RECIST v1.1 criteria. Where SBRT specific consensus response assessment criteria exist for specific sites (e.g. spine), progression of SBRT treated lesions will be defined according to these guidelines.
Time frame: The primary timepoint of most interest for PFS is at six months after trial entry
Time to first subsequent systemic therapy
Time to first subsequent systemic therapy is defined as time from trial entry to commencing next systemic line of therapy or death from any cause (if this occurs before commencement of first subsequent treatment).
Time frame: Time to first subsequent systemic therapy assessed up to 2 years after trial entry.
Time to first subsequent anti-cancer therapy
Time to first subsequent anti-cancer therapy is defined as time from trial entry to commencing next line of therapy (local or systemic) or death from any cause (if this occurs before commencement of first subsequent treatment).
Time frame: Time to first subsequent anti-cancer therapy assessed up to 2 years after trial entry.
Overall survival
Overall survival (OS) defined as time from trial entry to death from any cause.
Time frame: The primary timepoint of interest for OS is at two years after trial entry.
Local control at site of SBRT
Local control at site of SBRT is defined as time from trial entry until radiological evidence of progression at the treated site and be measured on a lesion based analysis using RECIST v1.1 criteria
Time frame: Local control at site of SBRT assessed up to 2 years after trial entry.
Time to 'Out of SBRT field' progression
Time to 'Out of SBRT field' progression is defined as time from trial entry until radiological evidence of progression outside of treated area(s) for SBRT treatment using RECIST v1.1.
Time frame: Time to 'Out of SBRT field' progression assessed up to 2 years after trial entry.
Clinician reported acute and late toxicity
Clinician reported acute and late toxicity will be graded using NCI CTCAE v5.0. Adverse events will be collected from start of treatment to disease progression (and 30 days post last dose of Niraparib for patients in cohort 1.
Time frame: Acute events are defined as those occurring up to 3 months follow up; late events are reported from 6 months post trial entry.
Quality of Life Assessments - FACT-O
Functional Assessment of Cancer Therapy - Ovarian (FACT-O): FACT-O is a self-report measure that assesses physical well-being, social/family well-being, emotional well-being, functional well-being and ovarian cancer-specific subscale. The higher the score, the better the QOL. Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression. Changes from baseline at each time point will be compared within groups as well as between treatment cohorts.
Time frame: Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression.
Quality of Life Assessments - EQ5D
EQ-5D-5L: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The higher the score, the better the QOL. Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression. Changes from baseline at each time point will be compared within groups as well as between treatment cohorts.
Time frame: Quality of Life will be collected at baseline prior to start of SBRT treatment, 4 weeks post SBRT treatment, 16, 24 and 48 weeks post trial entry and at disease progression.
Feasibility of recruitment rate for the trial
Feasibility of recruitment is defined as the recruitment rate for the trial
Time frame: Recruitment is expected to be over 2.5 years
Proportion of patients receiving SBRT in the absence of new developing widespread disease
Proportion of patients receiving SBRT in the absence of new developing widespread disease, defined as greater than or equal to 4 metastatic sites, regional or distant, or a combination thereof.
Time frame: Proportion of patients receiving SBRT in the absence of new developing widespread disease assessed up to 2 years after trial entry.
Time to widespread metastatic disease
Time to widespread metastatic disease will be measured from the time of trial entry until radiological evidence of widespread metastatic disease, defined as greater than or equal to 4 metastatic sites, regional or distant, or a combination thereof.
Time frame: Time to widespread metastatic disease assessed up to 2 years after trial entry.
Time to second subsequent therapy
Time to second subsequent therapy is defined as time from initiation of first subsequent therapy to commencing second line of therapy (local or systemic) or death (if this occurs before commencement of second subsequent treatment).
Time frame: Time to second subsequent therapy assessed up to 2 years after trial entry.
Mechanisms of PARP inhibitor resistance, immune-mediated effects, radiosensitivity and toxicities
Measurement of potential mechanisms of PARP inhibitor resistance, immune-mediated effects, radiosensitivity and toxicities. Measured between baseline and 4 weeks post-SBRT, 16, 24 and 48 weeks post trial entry, and disease progression.
Time frame: From date of trial entry until date of progression meeting the primary endpoint or date of death from any cause, whichever came first, assessed up to 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Dec 2027, 42 months after the start.
Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 42 months is below that.
Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Niraparib
Institute of Cancer Research, United Kingdom →