Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be female ≥18 years of age, able to understand study procedures, and agree to participate in the study by providing written informed consent.
Self-identify as Black. Please note that individuals who identify as Latino are eligible to participate so long as they also self-identify as Black.
Participant has completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.
Participant must have high-grade serous or high-grade endometrioid histology.
Disqualifiers
Any of the following histologies: low-grade serous carcinoma, grade 1 or 2 endometrioid adenocarcinoma, clear cell, mucinous, transitional cell, carcinosarcoma, undifferentiated, dedifferentiated
Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Primary progressive, platinum-refractory disease
Participant is at an increased risk of bleeding due to concurrent conditions (eg, major injuries or major surgery within the past 28 days before start of study treatment).
Trial design
Design model
Single group
Treatments tested in this trial
Niraparib
DrugNiraparib 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Niraparib Maintenance GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion 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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov