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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Niraparib will be administered orally (PO) daily as tablets at one of three possible dose levels, 100mg/day, 200mg/day or 300mg/day, based upon participant weight, platelet count, and certain drug combinations and conditions assessed at baseline.
Broward Health
Fort Lauderdale, Florida, United States
RECRUITINGUniversity of Florida Jacksonville
Jacksonville, Florida, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGAhmadu Bello University Teaching Hospital (ABUTH)
Zaria, Kaduna State, Nigeria
RECRUITINGProportion of Participants Experiencing Any Grade or Grade 3 or Higher of the Most Common Adverse Events (AEs) Previously Reported in the PRIMA trial (NCT02655016).
The proportion of participants in this study experiencing any grade or grade 3 or higher of the most common adverse events (AEs), of any treatment attribution, as those previously reported in the PRIMA Trial (NCT02655016). Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0. The most common adverse events previously reported include: Anemia, nausea, thrombocytopenia, constipation, fatigue, neutropenia, headache, insomnia, vomiting, abdominal pain, and hypertension.
Time frame: Up to 3 years
Proportion of Participants Experiencing Grade 3 or Higher Toxicity
The proportion of participants experiencing any grade or grade 3 or higher adverse events, and serious adverse events (SAEs) will be reported, regardless of treatment attribution. Adverse events (AEs) or serious adverse event (SAEs) leading to treatment discontinuation, dose reduction, dose interruption, or death will also be reported. Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 3 years
Proportion of Participants Experiencing Grade 3 or Higher Treatment-Related Adverse Event
The proportion of participants experiencing any grade or grade 3 or higher treatment-related adverse event (TRAE) will be reported. Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 3 years
Recurrence-Free Survival
Recurrence-free survival (RFS) among participants will be reported. RFS is defined as the elapsed time from the start date of study therapy to the date of recurrence as measured by cancer-antigen 125 (CA-125) levels in the blood and by computed tomography (CT) imaging utilizing Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria; or until date of death from any cause.
Time frame: Up to 3 years
Change in Health-Related Quality of Life (HRQOL) as Measured by FACT-GP5
Change in health-related quality of life among participants will be reported as measured by score on the Functional Assessment of Cancer Therapy-Item GP5 (FACT-GP5). FACT-GP5 is a single item, GP5, from the Functional Assessment of Cancer Therapy questionnaire, scored using a five-point Likert-type scale ranging from 0 to 4. A higher score indicates worsening health-related quality of life.
Time frame: Up to 3 years
Change in Health-Related Quality of Life (HRQOL) as Measured by FOSI
Change in health-related quality of life among participants will be reported as measured by scores on the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Symptom Index (FOSI). FOSI is a subset of the Functional Assessment of Cancer Therapy Ovarian Cancer containing eight items. Each item is scored using a five-point Likert-type scale ranging from 0 to 4 with higher scores indicating worsening health-related quality of life.
Time frame: Up to 3 years
Pharmacokinetics of Niraparib Measured By Cmax
The pharmacokinetics (PK) of niraparib among participants will be reported, measured as the maximal serum concentration (CMax).
Time frame: Up to 22 months
Pharmacokinetics of Niraparib Measured by AUC
The pharmacokinetics (PK) of niraparib among participants will be reported, measured as the area under the concentration curve (AUC).
Time frame: Up to 22 months
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