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
Qualifiers
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
Treatments tested in this trial
- Niraparib
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Miami
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov