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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 (N-Plus)

Trial Profile

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 (N-Plus)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 May 2025

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At a glance

  • Drugs Niraparib (Primary) ; Carboplatin; Niraparib; Paclitaxel
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Therapeutic Use
  • Acronyms N-Plus

Most Recent Events

  • 27 Apr 2025 Planned End Date changed from 1 May 2032 to 1 Oct 2032.
  • 27 Apr 2025 Planned primary completion date changed from 1 May 2027 to 1 Oct 2032.
  • 15 Nov 2024 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Jun 2024 to 25 Nov 2024.

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