Actively Recruiting
Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
Led by University of Miami · Updated on 2026-04-23
70
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.
CONDITIONS
Official Title
Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older who can understand study procedures and provide written consent
- Self-identify as Black, including those who identify as Latino and Black
- Completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer
- Have high-grade serous or high-grade endometrioid histology
- Provide saliva and/or blood samples for Fanconi Anemia germline mutation testing
- Provide tumor tissue from initial surgery or biopsy
- Have had a complete or partial clinical response confirmed by CT scan within 8 weeks after last platinum-based chemotherapy
- Recovered to Grade 1 or less toxicity from prior treatments
- No known allergy or contraindication to niraparib or its ingredients
- Considered candidates for maintenance niraparib therapy by their physician
- Adequate organ function including platelets, hemoglobin, liver enzymes, bilirubin, and kidney function as specified
- Patients with HIV allowed if meeting specific immune and viral load criteria and treatment guidelines
- Not pregnant or breastfeeding and either not of childbearing potential or using highly effective contraception with negative pregnancy test before treatment
- Agree to complete health-related quality of life and patient-reported outcome measures during the study
You will not qualify if you...
- Histologies of low-grade serous carcinoma, grade 1 or 2 endometrioid adenocarcinoma, clear cell, mucinous, transitional cell, carcinosarcoma, undifferentiated, or dedifferentiated
- History or current diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- Primary progressive or platinum-refractory disease
- Increased bleeding risk due to recent major injuries or surgery
- Diagnosis of platelet disorders such as TTP or ITP
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Uncontrolled high blood pressure (systolic >140 mmHg or diastolic >90 mmHg)
- Active second primary cancer
- Pregnant, breastfeeding, or planning pregnancy during treatment and 180 days after
- Received live vaccines within 30 days prior to treatment (COVID-19 vaccines without live virus allowed)
- Received blood transfusions or colony-stimulating factors within 4 weeks before treatment
- Recent radiotherapy affecting bone marrow or any radiation within 1 week before treatment
- Presence of leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastasis, or CNS bleeding
- Active pneumonitis or history requiring steroids or immunomodulatory treatment in last 90 days
- Active hepatitis B or C infection
- Prior posterior reversible encephalopathy syndrome
- Impaired decision-making capacity
- Serious uncontrolled medical conditions or infections that pose high medical risk
- Currently receiving other cancer treatments such as cytotoxic or hormonal therapies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Broward Health
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Ahmadu Bello University Teaching Hospital (ABUTH)
Zaria, Kaduna State, Nigeria
Actively Recruiting
Research Team
M
Matthew Schlumbrecht, MD, MPH
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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