Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
University of Miami
Study ID
NCT06412120
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2029
Completion
Aug 1, 2031

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib Maintenance Group
    Participants in this group will receive Niraparib maintenance therapy for up to 24 cycles, 28 days per cycle. Participants will be followed for up to one (1) year after completion of Niraparib therapy. Total participation is about three years.

Primary Outcome Measure

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). [ Time Frame: Up to 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Broward HealthFort LauderdaleFlorida33316
Scott Jordan, MD
[email protected]
Scott Jordan, MD (PRINCIPAL_INVESTIGATOR)
University of Florida JacksonvilleJacksonvilleFlorida32209
Karina E Hew, MD
[email protected]
904-383-1037
Karina E Hew, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Matthew Schlumbrecht, MD, MPH (PRINCIPAL_INVESTIGATOR)
Sophia HL George, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fort Lauderdale, FL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Broward Health· Fort Lauderdale, FLUniversity of Florida Jacksonville· Jacksonville, FLUniversity of Miami· Miami, FL

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