deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01847274

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

Sponsor: Cooperative Ovarian Cancer Group (COGI)

Conditions Ovarian Neoplasms Platinum Sensitive Ovarian Cancer
Interventions Active comparator: Niraparib placebo
Updated 18 times since 2017 Last updated: May 31, 2023 Started: Jun 21, 2013 Primary completion: Apr 22, 2016 Completion: Dec 26, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Ovarian Neoplasms and Platinum Sensitive Ovarian Cancer and is currently completed. Cooperative Ovarian Cancer Group (COGI) leads this study, which shows 18 recorded versions since 2013 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshot~Jun 2019 – ~Jul 2020 · 13 months · monthly snapshot~Jul 2020 – ~Nov 2020 · 4 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Nov 2021 · 5 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Feb 2023 · 11 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jul 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. May 2023 — Jul 2023 [monthly]

    Completed PHASE3

▶ Show 13 earlier versions

  1. Feb 2023 — May 2023 [monthly]

    Completed PHASE3

  2. Mar 2022 — Feb 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Dec 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Jun 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE3

  6. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  7. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  8. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Jul 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  10. Jun 2019 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Completed → Active Not Recruiting

  11. Jun 2018 — Jun 2019 [monthly]

    Completed PHASE3

  12. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  13. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Jun 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cooperative Ovarian Cancer Group (COGI)
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • Facing Our Risk of Cancer Empowered
  • Myriad Genetics, Inc.
  • Sarah Cannon
  • Tesaro, Inc.
  • US Oncology Research
Data source: Tesaro, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aalborg, Denmark , Abington, United States , Atlanta, United States , Austin, United States , Barcelona, Spain , Bebington, Wirral, United Kingdom , Bergen, Norway , Berlin, Germany , Besançon, France , Bialystok, Poland and 86 more locations