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Study Evaluating Safety, Tolerability, and Metabolism of Niraparib - Trial NCT06412120

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.

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NCT06412120
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06412120
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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

Study Focus

Ovarian Cancer

Niraparib

Interventional

drug

Sponsor & Location

University of Miami

Miami, United States of America

Timeline & Enrollment

Phase 4

Sep 01, 2024

Sep 01, 2029

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 ovary
Secondary malignant neoplasm of ovary
Benign neoplasm of ovary
Ovarian pregnancy
Ovarian dysfunction

Data Source

ClinicalTrials.gov

NCT06412120

Non-Device Trial