Actively Recruiting
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
Led by Sunnybrook Health Sciences Centre · Updated on 2023-11-22
40
Participants Needed
1
Research Sites
104 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
Researchers are evaluating an alternative dosing approach of niraparib in patients with newly diagnosed high-grade, advanced stage ovarian cancer. This single-arm phase II study focuses on patients who have completed at least four cycles of front-line platinum-based chemotherapy and have achieved a complete or partial response. The study aims to assess the frequency of blood-related and other side effects, dose interruptions, reductions, discontinuations, and progression-free survival at 24 months. Participants will receive oral niraparib starting at 100 mg daily for the first two 28-day cycles. If tolerated, the dose will increase to 200 mg daily for the third and fourth cycles. Patients will continue on their individualized dose until they experience side effects requiring dose adjustment or disease progression occurs. The study plans to enroll 40 patients at a single site. During the study, participants will provide blood samples before starting treatment, weekly for the first month, and as outlined in the protocol. Researchers will monitor adverse events, dose changes, and progression-free survival over two years. The study includes safety assessments and ongoing evaluations to understand how this dosing affects treatment continuation and patient outcomes.
CONDITIONS
Brief 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 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, including those undergoing neoadjuvant chemotherapy
- Completed at least 4 cycles of platinum-based chemotherapy with primary or interval debulking surgery
- Complete or partial tumor response (no lesion >1 cm) to platinum-based chemotherapy
- CA-125 levels normal or decreased by 90% during treatment and stable for at least 7 days
- Study drug can start within 12 weeks of completing chemotherapy
- Post-menopausal for over 1 year, surgically sterilized, or willing to use contraception or abstain from intercourse during and 6 months after treatment
- Negative pregnancy test within 3 days before starting treatment for patients of childbearing potential
- ECOG performance status of 0 or 1
- Adequate organ function including specified blood counts, kidney and liver function
- Controlled blood pressure if hypertensive
- Able to take oral medications
- Agree to provide blood samples as required by the study protocol
You will not qualify if you...
- Age under 18 years
- Pregnant, breastfeeding, or planning to conceive during treatment or for 6 months after
- Known allergy to niraparib or its components
- Previous treatment with PARP inhibitors or participation in related trials
- Enrolled in another investigational trial
- Received investigational therapy within 4 weeks or 5 half-lives of study drug
- Previous persistent or severe hematologic toxicity or fatigue from cancer therapy
- History or risk of myelodysplastic syndrome or acute myeloid leukemia
- Taking prohibited concurrent medications
- Recent major surgery within 3 weeks before study treatment
- Ascites drained within 4 weeks before study treatment
- Recent radiotherapy involving bone marrow or other areas
- Blood transfusion within 4 weeks before treatment
- Planning blood donation during or 90 days after treatment
- Diagnosis of another invasive cancer within 2 years (except treated skin cancer)
- Uncontrolled brain or leptomeningeal metastases
- Unstable steroid use
- Poor medical risk due to serious uncontrolled conditions or infections
- Immunocompromised status (except splenectomy)
- Active liver or biliary diseases except specified exceptions
- QT prolongation >470 milliseconds
- Known BRCA1 or BRCA2 mutation
- History of posterior reversible encephalopathy syndrome
- Live vaccine within 30 days before treatment
- Gastrointestinal conditions limiting absorption
- Significant cardiovascular disease
- Undergoing serial blood counts to meet eligibility
- Receiving blood transfusions to meet eligibility criteria
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 - Up to approximately 4 months (four 28-day cycles) or until disease progression or dose reduction is needed
Participants take oral niraparib once daily in a dose escalation design starting at 100 mg daily for two 28-day cycles, then increasing to 200 mg daily for the third and fourth 28-day cycles. They continue individualized dosing until adverse events require dose reduction or disease progression occurs.
Visits every 28 days during treatment cycles
Duration - Up to 2 years after treatment
Participants are monitored for up to 24 months after treatment to assess progression-free survival and adverse events.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
D
Dr. Allan Covens, MD
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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