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Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

StatusRecruiting
PhasePhase 4
Started2026-07-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 50 days later Jun 8, 2029 → Jul 28, 2029
See other at-risk trials from University of Miami

Amendment history

2026-08-03
Study Status v18
Primary completion pushed: 2029-06-08 → 2029-07-28
Completion pushed: 2031-06-08 → 2031-07-28
Start date2026-06-08→2026-07-28
2026-06-18
Study Status v17
Primary completion moved earlier: 2029-08-01 → 2029-06-08
Completion moved earlier: 2031-08-01 → 2031-06-08
Start dateestimated 2026-08-01→confirmed 2026-06-08
2026-06-01
Study Status, Contacts/Locations v16
Primary completion pushed: 2029-06-01 → 2029-08-01
Completion pushed: 2031-06-01 → 2031-08-01
Start date2026-06-01→2026-08-01
Study sites3→4
2026-04-21
Study Status, Contacts/Locations v15
Study sites2→3
2026-03-12
Study Status v14
Primary completion date2029-03-01→2029-06-01
Completion date2031-03-01→2031-06-01
Start date2026-03-01→2026-06-01
Show 13 earlier versions
2025-12-09
Study Status, Contacts/Locations v13
Primary completion date2028-10-01→2029-03-01
Completion date2030-10-01→2031-03-01
Start date2025-12-01→2026-03-01
Study sites1→2
2025-09-05
Suspended→Recruiting Study Status, Contacts/Locations v12
Trial statusSuspended→Recruiting
Reason stoppedPending submission and IRB approval of amendment→not stated
Study sitesdetails revised at 1 of 1 site
2025-08-28
Study Status v11
Start date2025-10-01→2025-12-01
2025-07-18
Study Status v10
Primary completion date2028-08-01→2028-10-01
Completion date2030-08-01→2030-10-01
Start date2025-08-01→2025-10-01
2025-06-16
Study Status v9
Primary completion date2028-06-01→2028-08-01
Completion date2030-06-01→2030-08-01
Start date2025-06-01→2025-08-01
2025-04-22
Recruiting→Suspended Study Status, Contacts/Locations v8
Trial statusRecruiting→Suspended
Reason stoppednot stated→Pending submission and IRB approval of amendment
Study sitesdetails revised at 1 of 1 site
2025-04-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-03-14
Study Status v6
Primary completion date2028-04-01→2028-06-01
Completion date2030-04-01→2030-06-01
Start date2025-04-01→2025-06-01
2025-01-10
Study Status v5
Primary completion date2028-02-01→2028-04-01
Completion date2030-02-01→2030-04-01
Start date2025-02-01→2025-04-01
2024-12-11
Study Status v4
Primary completion date2028-01-01→2028-02-01
Completion date2030-01-01→2030-02-01
Start date2025-01-01→2025-02-01
2024-10-07
Study Status v3
Primary completion date2027-11-01→2028-01-01
Completion date2029-11-01→2030-01-01
Start date2024-11-01→2025-01-01
2024-08-20
Study Status v2
Primary completion date2027-09-01→2027-11-01
Completion date2029-09-01→2029-11-01
Start date2024-09-01→2024-11-01
2024-05-14
Study Status, Eligibility v1
Eligibility criteria-159 characters
[...] rticipate in the study by providing written informed consent (Section 15.1). Self-identify as Black. Please note that individuals who i [...] ssment of germline mutation(s) in the Fanconi Anemia pathway (Section 10.4.2). Participant must provide formalin-fixed, paraffin-embedded [...] rgan function as defined below: Platelets ≥ 100 platelets × 10910^9/L Hemoglobin ≥ 9 g/dL or 5.6 mmol/L Aspartate transaminase [...] ns applies: Is not a woman of childbearing potential (WOCBP) as defined in Section 4.12, or Is a WOCBP and using a contraceptive method that is hig [...] odic testing should be carried out according to the pr [...]
2024-05-08
Original filing
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.
Trial Details
NCT Number NCT06412120
Lead Sponsor University of Miami
Collaborators: GlaxoSmithKline
Conditions Ovarian Cancer
Enrollment 70 participants
Start Date 2026-07-28
Primary Completion 2029-07-28 (estimated)
Study Completion 2031-07-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-05