Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer

A Phase II, Single-Arm Trial Assessing Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer: Dose Escalation

Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer (NCT05961124) is a Phase 2 interventional studying Ovarian Cancer and Stage III Ovarian Cancer, sponsored by Sunnybrook Health Sciences Centre. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this clinical trial is to test alternative dosing of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. The main questions it aims to answer are: What is the incidence of hematologic and other adverse events? What is the incidence of dose interruption, dose reduction and discontinuation? What is the length of time of progression-free survival at 24 months?

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion Criteria 1. Patients must be able to understand the study, agree to participate and provide written, willing to sign a consent form 2. Patients must be female and age \>/= 18 years of age 3. Newly diagnosed, diagnosed by tissue sample (biopsy-confirmed), high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment 4. Stage III and IV cancer according to International Federation of Gynecology and Obstetrics (FIGO) 2018 criteria and all patients undergoing neoadjuvant chemotherapy (NACT) 5. Patients must meet the following front-line treatment requirements: i. Patients must have completed a minimum of 4 cycles of platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin). Primary or interval debulking therapy and intraperitoneal chemotherapy are allowed. ii. Patients must have a complete response or partial tumor response (no lesion \>1cm) to platinum-based regimen iii. CA-125 must be either: 1. CA-125 in normal range or 2. CA-125 decreased by 90% during front-line treatment and stable for a minimum of 7 days (does not increase by more than 15%) iv. Study drug can start within 12 weeks of completing chemotherapy 6. Patients must be post-menopausal with no menses for \>1 year, or surgically sterilized, or willing to use adequate contraception to prevent pregnancy or abstain from intercourse and agrees not to donate eggs for the purpose of reproduction from study enrollment until 6 months following the last dose of treatment. i. Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin \[hcg\]) within 3 days prior to receiving the first dose of study treatment. 7. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 8. Patients must have your organs (liver, kidneys, etc.) are working well enough based on blood tests at enrollment, as follows: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria 1. Patients must be able to understand the study, agree to participate and provide written, informed consent 2. Patients must be female and age \>/= 18 years of age 3. Newly diagnosed, histologically confirmed, high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment 4. Stage III and IV cancer according to International Federation of Gynecology and Obstetrics (FIGO) 2018 criteria and all patients undergoing neoadjuvant chemotherapy (NACT) 5. Patients must meet the following front-line treatment requirements: i. Patients must have completed a minimum of 4 cycles of platinum-based chemotherapy (carboplatin, cisplatin, oxaliplatin). Primary or interval debulking therapy and intraperitoneal chemotherapy are allowed. ii. Patients must have a complete response or partial tumor response (no lesion \>1cm) to platinum-based regimen iii. CA-125 must be either: 1. CA-125 in normal range or 2. CA-125 decreased by 90% during front-line treatment and stable for a minimum of 7 days (does not increase by more than 15%) iv. Study drug can start within 12 weeks of completing chemotherapy 6. Patients must be post-menopausal with no menses for \>1 year, or surgically sterilized, or willing to use adequate contraception to prevent pregnancy or abstain from intercourse and agrees not to donate eggs for the purpose of reproduction from study enrollment until 6 months following the last dose of treatment. i. Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin \[hcg\]) within 3 days prior to receiving the first dose of study treatment. 7. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 8. Patients must have adequate organ function at enrollment, as follows: i. Absolute neutrophil count \>/= 1.5 x109/L ii. Platelets \>/= 100 x109/L iii. Hemoglobin \>/= 100 g/L without transfusion iv. Creatinine clearance \>/= 60 mL/min using the Cockcroft-Gault equation v. Total bilirubin \</= 1.5 times the upper limit of normal (ULN) or direct bilirubin \< 1 times the upper limit of normal vi. Aspartate aminotransferase and Alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN 9. Patients with hypertension should have their blood pressure adequately treated and controlled prior to starting study treatment 10. Patients must be able to take oral medications 11. Patients must agree to complete blood samples prior to cycle 1, then weekly for the first month and as outlined in the protocol Exclusion Criteria: 1. Patient's age is \<18 years. 2. Patient who are pregnant, breastfeeding, or expecting to conceive children during the study treatment of for 6 months after completion of the study treatment. 3. Patients with a known hypersensitivity to niraparib or any of its components 4. Patients who have received a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor as part of their previous treatment or participated in a trial where PARP inhibitors were administered in one arm of the trial. 5. Patients enrolled in another investigational trial 6. Patients who received another investigational therapy within 4 weeks or 5 halflives of the investigational agent, whichever is longer 7. Patients with previous persistent (\>4 weeks) or \>/= grade 3 hematologic toxicity or fatigue from prior cancer therapy. 8. Patients with known history of myelodysplastic syndrome or pre-treatment cytogenetic testing at risk for myelodysplastic syndrome or acute myeloid leukemia 9. Patients receiving concurrent, prohibited medications 10. Patients with previous major surgery within 3 weeks of starting study treatment and must have recovered from any effects of previous surgery. 11. Patients with ascites drained within 4 weeks of starting study treatment 12. Patients receiving palliative radiotherapy to \>20% of bone marrow within 2 weeks or any other radiotherapy within 1 week of study treatment 13. Patients receiving a transfusion (platelets or red blood cells) within 4 weeks of treatment 14. Patients planning to donate blood during the study or 90 days after treatment. 15. Patients with a diagnosis of another invasive cancer (other than ovarian cancer), within 2 years prior to randomization (except basal or squamous cell carcinoma of the skin that has been definitively treated i. Patients with uncontrolled brain or leptomeningeal metastases. Controlled brain or leptomeningeal metastasis is defined as: ii. Central nervous system disease that has undergone treatment with radiation or chemotherapy \> 1 month before study entry 16. No new or progressive signs or symptoms, stable steroid dose x 4 weeks or not taking steroids 17. Patients considered poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection i. Patients with known HIV considered high risk for serious and fatal outcome 18. Patients with evidence of any condition, therapy, or laboratory abnormality that might confound study results or patient participation for full duration of study (Ex. Myelodysplastic syndrome, anemia, leukopenia, neutropenia, thrombocytopenia, etc) 19. Patients who are immunocompromised (Patients with splenectomy are allowed) 20. Patients with known, active hepatic disease (Ex. Hepatitis B or C), active biliary disease (exceptions for Gilbert's syndrome, asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease as per investigator assessment) 21. Patients with QT prolongation \>470 milliseconds at screening 22. Patients with a known breast cancer susceptibility gene (BRCA1 and 2) mutation (as they routinely receive olaparib at our institution) If BRCA unknown they are not excluded. 23. Patients with a history of posterior reversible encephalopathy syndrome (PRES) 24. Patients who have had a live vaccine within 30 days of planned start date of study treatment 25. Patients with gastrointestinal abnormalities that may limit absorption 26. Patients with significant cardiovascular disease 27. Patients undergoing serial blood counts to achieve a value to meet eligibility 28. Patients receiving blood product transfusions in order to meet eligibility criteria

Treatments Being Tested

DRUG

Niraparib

Niraparib (Zejula) will be administered as an oral treatment once daily (continuously in a 28-day cycle). Niraparib will be administered in a dose escalation design where patients will start at a dose of 100 mg PO daily for the first two cycles (28-days each cycle), if tolerated, the dose will be increased to 200 mg PO daily for the third and fourth cycle.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sunnybrook Research Institute

Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05961124), the sponsor (Sunnybrook Health Sciences Centre), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05961124 clinical trial studying?

Who can participate in NCT05961124?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05961124?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05961124. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05961124. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.