Actively Recruiting
Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer
Led by Sunnybrook Health Sciences Centre · Updated on 2023-11-22
40
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Alternative Dosing Of Niraparib To Decrease Dose Interruption In First Line Maintenance Treatment For Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand the study, agree to participate, and provide written informed consent
- Female patients aged 18 years or older
- Newly diagnosed, histologically confirmed high-grade serous or grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment
- Stage III or IV cancer according to FIGO 2018 criteria; all patients undergoing neoadjuvant chemotherapy
- Completed at least 4 cycles of platinum-based chemotherapy with primary or interval debulking therapy allowed
- Complete or partial tumor response (no lesion >1 cm) to platinum-based regimen
- CA-125 level in normal range or decreased by 90% during front-line treatment and stable for at least 7 days
- Study drug can start within 12 weeks of completing chemotherapy
- Post-menopausal with no menses for more than 1 year, or surgically sterilized, or willing to use contraception or abstain from intercourse and not donate eggs from enrollment until 6 months after last dose
- Negative pregnancy test within 3 days prior to first dose for patients of childbearing potential
- ECOG performance status of 0 or 1
- Adequate organ function including specific blood counts, kidney and liver function criteria
- Blood pressure adequately treated and controlled prior to study treatment
- Able to take oral medications
- Agree to complete blood samples before cycle 1, weekly for the first month, and as outlined in the protocol
You will not qualify if you...
- Age less than 18 years
- Pregnant, breastfeeding, or planning to conceive during study treatment or for 6 months after
- Known allergy to niraparib or its components
- Prior treatment with PARP inhibitors or participation in trials involving PARP inhibitors
- Enrollment in another investigational trial
- Received investigational therapy within 4 weeks or 5 half-lives of that agent
- Previous persistent or grade 3 or higher hematologic toxicity or fatigue from prior cancer therapy
- History or risk of myelodysplastic syndrome or acute myeloid leukemia
- Use of concurrent prohibited medications
- Major surgery within 3 weeks of starting study treatment without full recovery
- Ascites drained within 4 weeks of study treatment start
- Recent palliative or other radiotherapy within specified time frames
- Blood transfusion within 4 weeks of treatment
- Planning to donate blood during study or 90 days after treatment
- Diagnosis of another invasive cancer within 2 years (except certain skin cancers)
- Uncontrolled brain or leptomeningeal metastases
- New or progressive symptoms or unstable steroid dose
- Poor medical risk due to serious uncontrolled conditions or infections
- Immunocompromised patients (splenectomy allowed)
- Active liver or biliary disease except specific stable conditions
- QT prolongation greater than 470 ms at screening
- Known BRCA1 or BRCA2 mutation
- History of posterior reversible encephalopathy syndrome
- Live vaccine within 30 days of planned treatment start
- Gastrointestinal abnormalities limiting absorption
- Significant cardiovascular disease
- Serial blood counts or blood transfusions to meet eligibility criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
D
Dr. Allan Covens, MD
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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