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A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

Study acronym: N-Plus
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial sites expanded: 47 → 50 locationsv7
  2. Study sites: 46 to 47v6
  3. Primary completion date: May 1, 2027 to Oct 1, 2032v5 Show 4 more changesShow less
    • Study sites: 9 to 46
    • Study completion date: May 1, 2032 to Oct 1, 2032
    • Start date changed from estimate of Nov 25, 2024 to Oct 11, 2024
    • Eligibility criteria expanded, about 74 words
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2024 to Nov 25, 2024
    • Study sites: 0 to 9
    v4
  5. Start date: Jan 1, 2024 to Jun 1, 2024v3
  6. Phase: Phase 3 to Phase 2v2 Show 6 more changesShow less
    • Primary completion date: Oct 1, 2025 to May 1, 2027
    • Start date: Oct 1, 2022 to Jan 1, 2024
    • Study completion date: Oct 1, 2030 to May 1, 2032
    • Study description revised
    • Study title expanded, about 13 words
    • Eligibility criteria shortened, about 2 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.
Trial Details
NCT Number NCT05460000
Lead Sponsor North Eastern German Society of Gynaecological Oncology
Collaborators: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Conditions
(from sponsor)		 Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Clear Cell Carcinoma
Related terms Adenocarcinoma, Clear Cell, Fallopian Tube Neoplasms, Ovarian Neoplasms
Enrollment 640 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov