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NCT06412120

Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance Following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry
University of Miami·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Ovarian Cancer
Drug/Device/Intervention
Niraparib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of Miami
Location
Miami, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Sep 01, 2024
End date
Sep 01, 2029
Enrollment
70 participants
Primary outcome

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).

Summary

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.

ICD-10 classifications
Malignant neoplasm of ovarySecondary malignant neoplasm of ovaryBenign neoplasm of ovaryOvarian pregnancyOvarian dysfunction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06412120
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06412120 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Miami and is currently Not yet recruiting. The study focuses on Ovarian Cancer. Target enrollment is 70 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.