deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03403712

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

Sponsor: Emerald Clinical Inc.

Conditions Chemotherapy-induced Nausea and Vomiting
Interventions dexamethasone fosnetupitant/ palonosetron netupitant/palonosetron
Updated 15 times since 2018 Last updated: May 15, 2020 Started: Mar 16, 2018 Primary completion: Sep 19, 2018 Completion: Sep 19, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03403712, this PHASE3 trial focuses on Chemotherapy-induced Nausea and Vomiting and remains completed. Sponsored by Emerald Clinical Inc., it has been updated 15 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~May 2019 · 3 months · monthly snapshot~May 2019 – ~May 2020 · 12 months · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

15 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. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

▶ Show 10 earlier versions

  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

  2. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. May 2020 — Jul 2020 [monthly]

    Completed PHASE3

  4. May 2019 — May 2020 [monthly]

    Completed PHASE3

  5. Feb 2019 — May 2019 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  6. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  7. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  8. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  9. Mar 2018 — May 2018 [monthly]

    Not Yet Recruiting PHASE3

  10. Feb 2018 — Mar 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Emerald Clinical Inc.
  • Helsinn Healthcare SA
  • The Physicians' Services Incorporated Foundation
Data source: Helsinn Healthcare SA

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

Study Locations

Anaheim, United States , Ashland, United States , Athens, United States , Bakersfield, United States , Baltimore, United States , Cheyenne, United States , Columbus, United States , Corona, United States , Dublin, United States , Elizabeth, United States and 27 more locations