OncoMatch/Clinical Trials/NCT06412120
Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
Is NCT06412120 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Niraparib for ovarian cancer.
Treatment: Niraparib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Disease stage
Required: Stage III, IV
Grade: high-grade seroushigh-grade endometrioid
Prior therapy
Must have received: platinum-based chemotherapy — adjuvant
Participant has completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer... must have had a complete or partial clinical response to adjuvant treatment as confirmed by CT scan within 8 weeks after completion of the last dose of platinum-based chemotherapy.
Cannot have received: cytotoxic chemotherapy
Patient is currently receiving one or more cytotoxic, hormonal, or other medications to treat their cancer.
Cannot have received: hormonal therapy
Patient is currently receiving one or more cytotoxic, hormonal, or other medications to treat their cancer.
Cannot have received: other medications to treat their cancer
Patient is currently receiving one or more cytotoxic, hormonal, or other medications to treat their cancer.
Lab requirements
Blood counts
Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
Kidney function
Creatinine <1.5 × ULN or eGFR ≥50 mL/min by Cockcroft-Gault (GFR 30-49 mL/min can be permissible depending on scenario)
Liver function
AST and ALT ≤2.5 × ULN (<5× in patients with known liver metastases); serum total bilirubin ≤ 1.5 × ULN (1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg daily)
Participants should have adequate organ function as defined below: Platelets ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL or 5.6 mmol/L; AST and ALT ≤2.5 × ULN (<5× in patients with known liver metastases); serum total bilirubin ≤ 1.5 × ULN (1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg daily); Creatinine <1.5 × ULN or eGFR ≥50 mL/min by Cockcroft-Gault (GFR 30-49 mL/min can be permissible depending on scenario)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Broward Health · Fort Lauderdale, Florida
- University of Miami · Miami, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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